Persona Total Knee System
133 catalogue numbers from 82-0153-194-04, listed by Zimmer, Inc., United States, under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer. 21 manufacturers in China are registered for this product code.
21manufacturers in China registered for this device type
133catalogue numbers in this listing
51510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Beijing (3). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| Changzhou Wastonortho Medical Appliance Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 5 |
Showing 12 of 21. All 21 manufacturers in China registered for Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | JWH |
| Device type | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3560 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K113369 |
| Record published | 2017-07-13 |
| Record revised | 2022-03-22 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | serial number |
| Sizes | Height 8 to 16 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 82-0153-194-04 | Size 4 | In distribution |
| 82-0156-880-05 | CR Provisional, Size 16, C-D, Left | In distribution |
| 82-0153-168-06 | Size 6 Left | In distribution |
| 82-0153-168-31 | Size 11 Right | In distribution |
| 82-0153-168-27 | Size 7 Right | In distribution |
| 82-0153-168-23 | Size 3 Right | In distribution |
| 82-0153-193-11 | Size 11 | In distribution |
| 82-0153-168-51 | Size 6-9 Right | In distribution |
| 82-0153-168-28 | Size 8 Right | In distribution |
| 82-0153-194-06 | Size 6 | In distribution |
| 82-0153-173-01 | Size 1 | In distribution |
| 82-0153-201-05 | Size 5 | In distribution |
| 82-0153-168-09 | Size 9 Left | In distribution |
| 82-0156-880-21 | CR Provisional, Size 11, E-F, Left | In distribution |
| 82-0153-173-09 | Size 9 | In distribution |
| 82-0153-168-24 | Size 4 Right | In distribution |
| 82-0153-201-06 | Size 6 | In distribution |
| 82-0156-858-82 | Height 8 mm | In distribution |
| 82-0156-880-47 | CR Provisional, Size 11, G-H, Right | In distribution |
| 82-0156-880-08 | CR Provisional, Size 12, C-D, Right | In distribution |
| 82-0156-880-02 | CR Provisional, Size 12, C-D, Left | In distribution |
| 82-0156-859-71 | UC Provisional, 7-12/ G/H, Right | In distribution |
| 82-0153-193-12 | Size 12 | In distribution |
| 82-0153-202-04 | Size 4 | In distribution |
| 82-0153-193-08 | Size 8 | In distribution |
| 82-0153-168-29 | Size 9 Right | In distribution |
| 82-0153-168-10 | Size 10 Left | In distribution |
| 82-0156-880-20 | CR Provisional, Size 10, E-F, Left | In distribution |
| 82-0152-714-40 | In distribution | |
| 82-0156-858-71 | CR Provisional, 3-9/ E-F, Left | In distribution |
| 82-0156-858-60 | Height 8 mm | In distribution |
| 82-0153-168-30 | Size 10 Right | In distribution |
| 82-0153-168-03 | Size 3 Left | In distribution |
| 82-0156-880-11 | CR Provisional, Size 16, C-D, Right | In distribution |
| 82-0156-858-62 | Height 8 mm | In distribution |
| 82-0153-168-40 | Size 3-5 Left | In distribution |
| 82-0153-193-10 | Size 10 | In distribution |
| 82-0156-880-28 | CR Provisional, Size 12, E-F, Right | In distribution |
| 82-0153-202-06 | Size 6 | In distribution |
| 82-0153-194-07 | Size 7 | In distribution |
| 82-0153-201-12 | Size 12 | In distribution |
| 82-0153-202-09 | Size 9 | In distribution |
| 82-0156-880-26 | CR Provisional, Size 10, E-F, Right | In distribution |
| 82-0156-880-48 | CR Provisional, Size 12, G-H, Right | In distribution |
| 82-0153-201-08 | Size 8 | In distribution |
| 82-0153-194-08 | Size 8 | In distribution |
| 82-0156-880-51 | CR Provisional, Size 16, G-H, Right | In distribution |
| 82-0156-880-10 | CR Provisional, Size 14, C-D, Right | In distribution |
| 82-0153-173-04 | Size 4 | In distribution |
| 82-0153-202-11 | Size 11 | In distribution |
| 82-0156-880-46 | CR Provisional, Size 10, G-H, Right | In distribution |
| 82-0153-168-41 | Size 6-9 Left | In distribution |
| 82-0153-202-07 | Size 7 | In distribution |
| 82-0153-202-03 | Size 3 | In distribution |
| 82-0153-194-05 | Size 5 | In distribution |
| 82-0156-858-72 | Height 8 mm | In distribution |
| 82-0156-880-06 | CR Provisional, Size 10, C-D, Right | In distribution |
| 82-0156-859-70 | Height 16 mm | In distribution |
| 82-0153-168-42 | Size 10-12 Left | In distribution |
| 82-0152-714-19 | In distribution | |
| 82-0153-168-26 | Size 6 Right | In distribution |
| 82-0153-173-11 | Size 11 | In distribution |
| 82-0153-173-03 | Size 3 | In distribution |
| 82-0153-193-03 | Size 3 | In distribution |
| 82-0156-880-43 | CR Provisional, Size 13, G-H, Left | In distribution |
| 82-0153-168-05 | Size 5 Left | In distribution |
| 82-0156-858-70 | Height 8 mm | In distribution |
| 82-0156-880-09 | CR Provisional, Size 13, C-D, Right | In distribution |
| 82-0156-880-29 | CR Provisional, Size 13, E-F, Right | In distribution |
| 82-0156-858-83 | CR Provisional, 3-9/ G-H, Right | In distribution |
| 82-0156-880-23 | CR Provisional, Size 13, E-F, Left | In distribution |
| 82-0153-173-02 | Size 2 | In distribution |
| 82-0153-173-08 | Size 8 | In distribution |
| 82-0156-858-81 | CR Provisional, 3-9/ G-H, Left | In distribution |
| 82-0156-880-49 | CR Provisional, Size 13, G-H, Right | In distribution |
| 82-0153-168-08 | Size 8 Left | In distribution |
| 82-0152-714-52 | In distribution | |
| 82-0153-201-07 | Size 7 | In distribution |
| 82-0153-202-05 | Size 5 | In distribution |
| 82-0153-201-04 | Size 4 | In distribution |
| 82-0156-859-60 | Height 16 mm | In distribution |
| 82-0153-202-12 | Size 12 | In distribution |
| 82-0153-201-09 | Size 9 | In distribution |
| 82-0153-193-06 | Size 6 | In distribution |
| 82-0153-173-10 | Size 10 | In distribution |
| 82-0153-168-52 | Size 10-12 Right | In distribution |
| 82-0156-880-44 | CR Provisional, Size 14, G-H, Left | In distribution |
| 82-0153-168-25 | Size 5 Right | In distribution |
| 82-0153-168-04 | Size 4 Left | In distribution |
| 82-0156-858-80 | Height 8 mm | In distribution |
| 82-0153-201-10 | Size 10 | In distribution |
| 82-0152-714-00 | In distribution | |
| 82-0156-880-01 | CR Provisional, Size 11, C-D, Left | In distribution |
| 82-0156-880-00 | CR Provisional, Size 10, C-D, Left | In distribution |
| 82-0156-880-07 | CR Provisional, Size 11, C-D, Right | In distribution |
| 82-0156-880-50 | CR Provisional, Size 14, G-H, Right | In distribution |
| 82-0156-880-03 | CR Provisional, Size 13, C-D, Left | In distribution |
| 82-0156-859-50 | Height 16 mm | In distribution |
| 82-0156-858-61 | CR Provisional, 3-9/ C-D, Left | In distribution |
| 82-0156-880-25 | CR Provisional, Size 16, E-F, Left | In distribution |
| 82-0153-201-11 | Size 11 | In distribution |
| 82-0156-880-45 | CR Provisional, Size 16, G-H, Left | In distribution |
| 82-0156-858-63 | CR Provisional, 3-9/ C-D, Right | In distribution |
| 82-0156-858-73 | CR Provisional, 3-9/ E-F, Right | In distribution |
| 82-0153-202-10 | Size 10 | In distribution |
| 82-0153-194-09 | Size 9 | In distribution |
| 82-0156-880-31 | CR Provisional, Size 16, E-F, Right | In distribution |
| 82-0156-880-30 | CR Provisional, Size 14, E-F, Right | In distribution |
| 82-0153-173-05 | Size 5 | In distribution |
| 82-0156-859-61 | UC Provisional, 4-11/ E/F, Right | In distribution |
| 82-0156-880-04 | CR Provisional, Size 14, C-D, Left | In distribution |
| 82-0153-194-11 | Size 11 | In distribution |
| 82-0153-202-08 | Size 8 | In distribution |
| 82-0156-880-22 | CR Provisional, Size 12, E-F, Left | In distribution |
| 82-0153-193-04 | Size 4 | In distribution |
| 82-0153-168-11 | Size 11 Left | In distribution |
| 82-0153-193-05 | Size 5 | In distribution |
| 82-0153-194-10 | Size 10 | In distribution |
| 82-0156-880-24 | CR Provisional, Size 14, E-F, Left | In distribution |
| 82-0153-201-03 | Size 3 | In distribution |
| 82-0156-880-27 | CR Provisional, Size 11, E-F, Right | In distribution |
| 82-0156-859-51 | UC Provisional, 3-7/ C/D, Right | In distribution |
| 82-0153-168-50 | Size 3-5 Right | In distribution |
| 82-0153-168-07 | Size 7 Left | In distribution |
| 82-0153-173-12 | Size 12 | In distribution |
| 82-0153-173-07 | Size 7 | In distribution |
| 82-0156-880-42 | CR Provisional, Size 12, G-H, Left | In distribution |
| 82-0156-880-41 | CR Provisional, Size 11, G-H, Left | In distribution |
| 82-0156-880-40 | CR Provisional, Size 10, G-H, Left | In distribution |
| 82-0153-193-09 | Size 9 | In distribution |
| 82-0153-193-07 | Size 7 | In distribution |
| 82-0153-173-06 | Size 6 | In distribution |
| 82-0153-201-00 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prophecy® | Microport Orthopedics Inc. | 4,423 |
| Exult Knee Replacement System | Corentec Co., Ltd. | 1,770 |
| Freedom | Maxx Orthopedics Inc. | 1,693 |
| Legion | Smith & Nephew, Inc. | 1,534 |
| MyKnee | Medacta International SA | 1,466 |
| Journey | Smith & Nephew, Inc. | 1,339 |
| Persona® | Zimmer, Inc. | 1,254 |
| DJO Surgical | Encore Medical, L.P. | 1,131 |
| U2 Total Knee System | United Orthopedic Corp. | 1,078 |
| CKS Plus | Shalby Advanced Technologies, Inc. | 1,024 |
| Lospa Modular Knee System | Corentec Co., Ltd. | 1,020 |
| Natural-Knee® | Zimmer, Inc. | 980 |
Showing 12 of 1,175. All products under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243724 | 2025-03-06 |
| K230321 | 2023-03-08 |
| K221479 | 2022-11-17 |
| K210829 | 2021-05-18 |
| K210551 | 2021-03-18 |
| K200209 | 2020-03-24 |
| K193223 | 2020-01-24 |
| K191625 | 2019-09-05 |
| K190068 | 2019-06-04 |
| K183583 | 2019-05-10 |
| K181947 | 2018-10-25 |
| K173057 | 2018-03-29 |
| K152494 | 2015-11-25 |
| K142787 | 2014-12-22 |
| K133737 | 2014-02-04 |
| K130143 | 2013-02-22 |
| K122765 | 2012-11-09 |
| K113369 | 2012-03-27 |
| K073286 | 2008-03-07 |
| K072281 | 2007-09-06 |
| K062768 | 2006-10-13 |
| K061882 | 2006-08-01 |
| K060722 | 2006-05-26 |
| K060370 | 2006-04-28 |
| K052879 | 2005-11-22 |
| K050723 | 2005-04-20 |
| K043101 | 2005-03-07 |
| K042271 | 2004-10-13 |
| K023211 | 2002-10-17 |
| K013991 | 2001-12-27 |
| K003910 | 2001-03-19 |
| K991581 | 1999-07-30 |
| K972774 | 1999-05-05 |
| K972270 | 1997-11-24 |
| K963148 | 1997-02-13 |
| K962196 | 1996-08-23 |
| K960279 | 1996-04-26 |
| K951185 | 1996-03-15 |
| K946150 | 1995-07-11 |
| K933785 | 1995-01-30 |
| K930831 | 1993-11-16 |
| K911572 | 1991-07-01 |
| K895639 | 1990-02-08 |
| K892800 | 1989-08-03 |
| K872379 | 1987-10-28 |
| K863805 | 1986-12-02 |
| K853661 | 1985-12-09 |
| K834432 | 1984-04-11 |
| K833363 | 1984-02-13 |
| K830121 | 1983-04-26 |
| K790219 | 1979-05-08 |
Recalls Naming This Product
39 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Zimmer, Inc. | 510(k) number | 2017-08-07 | Class II | Under Investigation by firm | There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the | 842 products in total | 2018-08-23 |
| Zimmer, Inc. | 510(k) number | 2017-08-07 | Class II | Under Investigation by firm | There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the | 842 products in total | 2018-08-23 |
| Zimmer, Inc. | 510(k) number | 2017-08-07 | Class II | Under Investigation by firm | There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the | 842 products in total | 2018-08-23 |
| Zimmer, Inc. | 510(k) number | 2017-08-07 | Class II | Under Investigation by firm | There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the | 842 products in total | 2018-08-23 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-03-17 | Class II | Employee error | The firm received a customer complaint establishing that the product (Persona PS Articular Surfaces)information shown on the box differed by sides. One side showed P/N: 42-5114-008-18/ Lot: 62632101 and the other side showed P/N: 42-5114-0 | TBD | 2017-03-14 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-03-17 | Class II | Employee error | The firm received a customer complaint establishing that the product (Persona PS Articular Surfaces)information shown on the box differed by sides. One side showed P/N: 42-5114-008-18/ Lot: 62632101 and the other side showed P/N: 42-5114-0 | TBD | 2017-03-14 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-01-11 | Class II | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile. | 112588 | 2017-04-13 |
| Zimmer, Inc. | 510(k) number | 2015-03-10 | Class II | Nonconforming Material/Component | Zimmer, Inc is voluntarily recalling 22 lots of Persona Anterior Referencing Sizer with Locking Boom, part number 42-5099-088-10. Devices are being removed from distribution due to nonconforming to print specifications. | 688 | 2015-11-06 |
| Zimmer, Inc. | 510(k) number | 2014-12-04 | Class II | Process design | The affected lot was supplied by contract manufacturer and are potentially subject to disassociation of the magnet cover. Zimmer received one complaint indicating the magnet cover of a Persona Cemented Tibial Broach Inserter/Extractor Handl | 83 units | 2015-05-13 |
| Zimmer, Inc. | 510(k) number | 2014-11-25 | Class II | Process control | Potential for fracture of the tip of the product. The fractured tip is approximately 4mm x 7mm x 3.5mm in size. Retained tip may result in: pain, soft tissue irritation, soft tissue damage, or increased wear due to contact with the fracture | 1,091 | 2015-12-01 |
| Zimmer, Inc. | 510(k) number | 2014-10-09 | Class II | Nonconforming Material/Component | Cleaning process validation failure. | 138 units | 2015-06-24 |
| Zimmer, Inc. | 510(k) number | 2014-10-07 | Class II | Process control | Affected product did not undergo heat treatment hardening step leading to the potential for deformation of the tip. | 618 units | 2015-09-23 |
| Zimmer, Inc. | 510(k) number | 2014-08-07 | Class II | Device Design | Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument | 77,737 units total | 2015-01-27 |
| Zimmer, Inc. | 510(k) number | 2014-08-07 | Class II | Device Design | Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument | 77,737 units total | 2015-01-27 |
| Zimmer, Inc. | 510(k) number | 2014-08-07 | Class II | Device Design | Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument | 77,737 total units | 2015-01-27 |
| Zimmer, Inc. | 510(k) number | 2014-08-07 | Class II | Device Design | Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument | 77,737 total units | 2015-01-27 |
| Zimmer, Inc. | 510(k) number | 2014-08-07 | Class II | Device Design | Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument | 77,737 total units | 2015-01-27 |
| Zimmer, Inc. | 510(k) number | 2014-08-07 | Class II | Device Design | Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument | 77,737 total units | 2015-01-27 |
| Zimmer, Inc. | 510(k) number | 2013-06-10 | Class II | Device Design | Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer’s corrective actions taken earlier this year concerning the TASPs. | 70,986 distribution events | 2014-09-11 |
| Zimmer, Inc. | 510(k) number | 2013-06-10 | Class II | Device Design | Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer’s corrective actions taken earlier this year concerning the TASPs. | 70,986 distribution events | 2014-09-11 |
| Zimmer, Inc. | 510(k) number | 2013-06-10 | Class II | Device Design | Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer’s corrective actions taken earlier this year concerning the TASPs. | 70,986 distribution events | 2014-09-11 |
| Zimmer, Inc. | 510(k) number | 2012-11-14 | Class II | Device Design | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instr | 318 | 2014-04-16 |
| Zimmer, Inc. | 510(k) number | 2012-11-14 | Class II | Device Design | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instr | 518 | 2014-04-16 |
| Zimmer, Inc. | 510(k) number | 2012-11-14 | Class II | Device Design | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instr | 591 | 2014-04-16 |
| Zimmer, Inc. | 510(k) number | 2012-11-14 | Class II | Device Design | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instr | 429 | 2014-04-16 |
| Zimmer, Inc. | 510(k) number | 2012-11-14 | Class II | Device Design | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instr | 346 | 2014-04-16 |
| Zimmer, Inc. | 510(k) number | 2012-11-14 | Class II | Device Design | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instr | 195 | 2014-04-16 |
| Zimmer, Inc. | 510(k) number | 2012-11-14 | Class II | Device Design | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instr | 135 | 2014-04-16 |
| Zimmer, Inc. | 510(k) number | 2012-11-14 | Class II | Device Design | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instr | 94 | 2014-04-16 |
| Zimmer, Inc. | 510(k) number | 2012-11-14 | Class II | Device Design | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instr | 93 | 2014-04-16 |
| Zimmer, Inc. | 510(k) number | 2012-11-14 | Class II | Device Design | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instr | 92 | 2014-04-16 |
| Zimmer, Inc. | 510(k) number | 2012-11-14 | Class II | Device Design | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instr | 92 | 2014-04-16 |
| Zimmer, Inc. | 510(k) number | 2012-11-14 | Class II | Device Design | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instr | 189 | 2014-04-16 |
| Zimmer, Inc. | 510(k) number | 2012-11-14 | Class II | Device Design | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instr | 189 | 2014-04-16 |
| Zimmer, Inc. | 510(k) number | 2012-11-14 | Class II | Device Design | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instr | 188 | 2014-04-16 |
| Zimmer, Inc. | 510(k) number | 2012-11-14 | Class II | Device Design | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instr | 188 | 2014-04-16 |
| Zimmer, Inc. | 510(k) number | 2012-11-14 | Class II | Device Design | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instr | 189 | 2014-04-16 |
| Zimmer, Inc. | 510(k) number | 2012-11-14 | Class II | Device Design | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instr | 189 | 2014-04-16 |
| Zimmer, Inc. | 510(k) number | 2012-09-07 | Class II | Device Design | Zimmer is initiating a recall of the Cemented Tibial Drill for the Zimmer Persona Personalized Knee System due to three reports being received as of August 29. 2012 for tibial cortex perforation during preparation of the tibial bone. The in | 60 | 2014-04-17 |
Recalls
36 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-02-27 | Class II | Labeling Change Control | The “Use with plate 7, 8, 9, 10” compatibility statement on top of the label does not match with the compatibility statements “USE WITH PLATE 5, 6” in the translations section of the same label. | 76 units | |
| 2025-01-06 | Class II | Process change control | It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope. | 155 units | |
| 2025-01-06 | Class II | Process change control | It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope. | 155 units | |
| 2024-03-28 | Class II | Process change control | Out of specification violation of devices that results in a gap existing within the fixture that presses the fiber metal pad to the substrate, causing the pad to not fully bond to the substrate. | 5,546 units | |
| 2023-05-19 | Class II | Under Investigation by firm | Device outer packaging was incorrectly labeled. | 2026-05-29 | |
| 2022-12-06 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used wit | 1366 | |
| 2022-12-06 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used wit | 1049 | |
| 2022-12-06 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used wit | 1673 | |
| 2022-12-06 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used wit | 2092 | |
| 2022-12-06 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used wit | 284 | |
| 2022-12-06 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used wit | 2460 | |
| 2019-10-10 | Class II | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 5,459,583 total devices | 2020-05-19 |
| 2019-10-10 | Class II | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 5,459,583 total devices | 2020-05-19 |
| 2018-10-31 | Class II | Process control | Screw is missing from the package | 19 units | 2019-04-08 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-04-28 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a lot-specific medical device field action for two lots of the NexGen Offset Stem Extension implants. Product complaints indicated that the size etched on the part and labeled on the product packaging were incorr | 24 | 2018-07-03 |
| 2016-01-11 | Class II | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. | 32508 | 2017-05-23 |
| 2016-01-11 | Class II | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. | 88389 | 2017-05-23 |
| 2016-01-11 | Class II | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. | 117359 | 2017-05-23 |
| 2016-01-11 | Class II | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. | 42064 | 2017-05-23 |
| 2016-01-11 | Class II | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. | 61485 | 2017-05-23 |
| 2016-01-11 | Class II | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. | 18093 | 2017-05-23 |
| 2016-01-11 | Class II | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. | 84396 | 2017-05-23 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.