Washer, Bolt Nut
308 catalogue numbers from 47-4827-030-00, listed by Zimmer, Inc., United States, under Washer, Bolt Nut. 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
308catalogue numbers in this listing
1510(k) clearance
1recall
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (3), Zhejiang (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Suzhou Endophix Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 17 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | HTN |
| Device type | Washer, Bolt Nut |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K112885 |
| Record published | 2015-09-24 |
| Record revised | 2025-02-06 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 6 to 150 mm; outer diameter 0.9 to 7.5 mm; height 2 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 47-4827-030-00 | Length 30 mm | In distribution | |
| 47-4820-040-02 | Length 40 mm | In distribution | |
| 515027070 | TX6 | In distribution | |
| 47-4815-009-03 | 1.5 mm, Cortical Screw | In distribution | |
| 4865-110 | 6.5 mm Cancellous Screw | In distribution | |
| 28.20.110 | Length 10 mm | In distribution | |
| 519016150 | TX8 | In distribution | |
| 47-4840-010-01 | Length 10 mm | In distribution | |
| 35.23.026 | Length 26 mm | In distribution | |
| 47-4815-007-01 | Length 7 mm | In distribution | |
| 47-4845-056-01 | 4.5 mm, Cortical Screw | In distribution | |
| 47-4865-110-01 | Length 110 mm | In distribution | |
| 28.03.014 | Length 66 mm | In distribution | |
| 4845-50-08 | Length 50 mm | In distribution | |
| 47-4840-045-00 | Length 45 mm | In distribution | |
| 47-4865-115-02 | Length 115 mm | In distribution | |
| 47-4820-012-01 | 2.0 mm, Cortical Screw | In distribution | |
| 515013070 | Outer Diameter 3.1 mm | In distribution | |
| 47-4845-044-01 | 4.5 mm, Cortical Screw | In distribution | |
| 47-4815-014-01 | 1.5 mm, Cortical Screw | In distribution | |
| 47-4827-065-00 | Length 65 mm | In distribution | |
| 47-4835-020-00 | 3.5 mm, Cortical Screw | In distribution | |
| 47-4865-065-00 | Length 65 mm | In distribution | |
| 47-4865-065-02 | Length 65 mm | In distribution | |
| 47-4840-038-00 | Length 38 mm | In distribution | |
| 4845-58-04 | 4.5 mm Shaft Screw | In distribution | |
| 35.23.028 | TX6 | In distribution | |
| 47-4820-016-00 | 2.0 mm, Cortical Screw | In distribution | |
| 47-4840-030-00 | 4.0 mm, Cancellous Screw | In distribution | |
| 28.08.207 | Height 2 mm | In distribution | |
| 47-4835-090-00 | Length 90 mm | In distribution | |
| 47-4840-040-01 | Length 40 mm | In distribution | |
| 4865-70-01 | 6.5 mm Cancellous Screw, 16 mm Thread Length | In distribution | |
| 47-4840-030-01 | Length 30 mm | In distribution | |
| 47-4835-135-00 | Length 135 mm | In distribution | |
| 47-4835-085-00 | 3.5 mm, Cortical Screw | In distribution | |
| 47-4820-030-00 | 2.0 mm, Cortical Screw | In distribution | |
| 47-4840-075-00 | Length 75 mm | In distribution | |
| 47-4865-090-01 | Length 90 mm | In distribution | |
| 28.23.035 | for MiniCan screw 3.5mm | In distribution | |
| 47-4827-008-00 | Length 8 mm | In distribution | |
| 47-4840-014-00 | Length 14 mm | In distribution | |
| 35.18.026 | Outer Diameter 1.8 mm | In distribution | |
| 47-4865-070-00 | 6.5 mm, Cancellous Screw | In distribution | |
| 4845-30-08 | 4.5 mm Malleolar Screw | In distribution | |
| 28.24.136 | Length 36 mm | In distribution | |
| 28.24.050 | TX10 | In distribution | |
| 47-4835-110-00 | Length 110 mm | In distribution | |
| 47-4835-140-00 | 3.5 mm Cortical Screw | In distribution | |
| 47-4865-065-01 | 6.5 mm, Cancellous Screw, 16 mm Thread Length | In distribution | |
| 28.80.036 | Outer Diameter 4.5 mm | In distribution | |
| 28.44.085 | TX25 | In distribution | |
| 4845-40 | 4.5 mm Cortical Screw | In distribution | |
| 28.80.024 | Outer Diameter 4.5 mm | In distribution | |
| 28.22.138 | Length 38 mm | In distribution | |
| 47-4845-064-01 | Length 64 mm | In distribution | |
| 47-4820-010-00 | 2.0 mm, Cortical Screw | In distribution | |
| 47-4865-105-02 | Length 105 mm | In distribution | |
| 47-4845-025-08 | Length 25 mm | In distribution | |
| 47-4840-040-00 | 4.0 mm, Cancellous Screw | In distribution | |
| 605092100 | Length 100 mm | 10 | In distribution |
| 47-4840-065-01 | 4.0 mm, Cancellous Screw | In distribution | |
| 35.18.014 | TX6 | In distribution | |
| 28.44.120 | TX25 | In distribution | |
| 47-4845-038-01 | 4.5 mm, Cortical Screw | In distribution | |
| 35.18.016 | Length 16 mm | In distribution | |
| 35.23.030 | TX6 | In distribution | |
| 4845-66-01 | 4.5 mm Cortical Screw | In distribution | |
| 47-4820-012-03 | Length 12 mm | In distribution | |
| 47-4845-030-08 | 4.5 mm, Malleolar Screw | In distribution | |
| 47-4840-028-00 | Length 28 mm | In distribution | |
| 47-4865-020-00 | 6.5 mm, Cancellous Screw | In distribution | |
| 35.23.010 | Outer Diameter 2.3 mm | In distribution | |
| 28.01.003 | 3mm step, Sys 3.5 | In distribution | |
| 47-4827-045-00 | Length 45 mm | In distribution | |
| 28.22.130 | HEX | In distribution | |
| 519012150 | TX8 | In distribution | |
| 47-4865-025-00 | 6.5 mm, Cancellous Screw | In distribution | |
| 47-4815-012-00 | Length 12 mm | In distribution | |
| 47-4845-016-01 | 4.5 mm, Cortical Screw | In distribution | |
| 47-4840-055-00 | 4.0 mm, Cancellous Screw | In distribution | |
| 28.22.160 | Length 60 mm | In distribution | |
| 47-4845-080-01 | Length 80 mm | In distribution | |
| 28.80.075 | TX10 | In distribution | |
| 47-4827-020-00 | Length 20 mm | In distribution | |
| 28.44.065 | TX25 | In distribution | |
| 47-4815-006-03 | 1.5 mm, Cortical Screw | In distribution | |
| 47-4840-050-00 | 4.0 mm, Cancellous Screw | In distribution | |
| 47-4865-100-02 | Length 100 mm | In distribution | |
| 47-4840-075-01 | Length 75 mm | In distribution | |
| 47-4835-028-00 | Length 28 mm | In distribution | |
| 47-4820-010-01 | Length 10 mm | In distribution | |
| 47-4820-006-03 | Length 6 mm | In distribution | |
| 47-4840-070-01 | Length 70 mm | In distribution | |
| 47-4865-095-00 | 6.5 mm, Cancellous Screw | In distribution | |
| 4865-50-02 | Length 50 mm | In distribution | |
| 47-4820-018-00 | Length 18 mm | In distribution | |
| 28.22.112 | HEX | In distribution | |
| 519024150 | TX8 | In distribution | |
| 47-4840-080-01 | 4.0 mm, Cancellous Screw | In distribution | |
| 47-4835-038-00 | Length 38 mm | In distribution | |
| 28.44.075 | TX25 | In distribution | |
| 4845-56-04 | 4.5 mm Shaft Screw | In distribution | |
| 47-4865-080-02 | 6.5 mm, Cancellous Screw, 32 mm Thread Length | In distribution | |
| 515020070 | Outer Diameter 3.1 mm | In distribution | |
| 28.44.060 | Length 60 mm | In distribution | |
| 28.20.132 | Outer Diameter 3.5 mm | In distribution | |
| 4845-30-04 | 4.5 mm Shaft Screw | In distribution | |
| 47-4835-070-00 | Length 70 mm | In distribution | |
| 4845-85 | Length 85 mm | In distribution | |
| 47-4865-110-02 | Length 110 mm | In distribution | |
| 47-4865-120-02 | Length 120 mm | In distribution | |
| 47-4845-048-01 | Length 48 mm | In distribution | |
| 28.24.060 | Length 60 mm | In distribution | |
| 47-4815-011-03 | 1.5 mm, Cortical Screw | In distribution | |
| 28.44.110 | Outer Diameter 7.5 mm | In distribution | |
| 47-4835-024-00 | 3.5 mm, Cortical Screw | In distribution | |
| 47-4835-030-04 | Length 30 mm | In distribution | |
| 47-4845-056-04 | 4.5 mm, Shaft Screw | In distribution | |
| 28.20.022 | Outer Diameter 3.5 mm | In distribution | |
| 47-4845-026-01 | Length 26 mm | In distribution | |
| 4845-46-04 | 4.5 mm Shaft Screw | In distribution | |
| 47-4820-034-03 | 2.0 mm, Cortical Screw | In distribution | |
| 28.80.034 | TX10 | In distribution | |
| 47-4815-011-01 | 1.5 mm, Cortical Screw | In distribution | |
| 47-4820-036-03 | Length 36 mm | In distribution | |
| 47-4820-024-03 | Length 24 mm | In distribution | |
| 47-4835-055-00 | 3.5 mm, Cortical Screw | In distribution | |
| 515022070 | Outer Diameter 3.1 mm | In distribution | |
| 47-4845-062-01 | 4.5 mm, Cortical Screw | In distribution | |
| 47-4827-028-00 | Length 28 mm | In distribution | |
| 28.44.050 | Outer Diameter 7.5 mm | In distribution | |
| 47-4835-026-04 | Length 26 mm | In distribution | |
| 28.80.032 | Length 32 mm | In distribution | |
| 47-4845-040-08 | Length 40 mm | In distribution | |
| 47-4840-010-00 | 4.0 mm, Cancellous Screw | In distribution | |
| 519023150 | TX8 | In distribution | |
| 4845-60 | Length 60 mm | In distribution | |
| 35.23.034 | Outer Diameter 2.3 mm | In distribution | |
| 47-4845-052-01 | Length 52 mm | In distribution | |
| 28.02.008 | 8mm stem, Sys 3.5 | In distribution | |
| 47-4865-040-01 | 6.5 mm, Cancellous Screw, 16 mm Thread Length | In distribution | |
| 47-4845-032-01 | Length 32 mm | In distribution | |
| 28.44.090 | TX25 | In distribution | |
| 28.44.045 | Outer Diameter 7.5 mm | In distribution | |
| 519028150 | TX8 | In distribution | |
| 47-4820-026-01 | 2.0 mm, Cortical Screw | In distribution | |
| 28.44.095 | TX25 | In distribution | |
| 47-4865-100-01 | 6.5 mm, Cancellous Screw, 16 mm Thread Length | In distribution | |
| 47-4835-024-04 | Length 24 mm | In distribution | |
| 28.80.050 | Length 50 mm | In distribution | |
| 22.28.323 | Outer Diameter 1.3 mm | 6 | In distribution |
| 47-4815-022-01 | Length 22 mm | In distribution | |
| 47-4845-065-08 | 4.5 mm, Malleolar Screw | In distribution | |
| 47-4865-075-02 | 6.5 mm, Cancellous Screw, 32 mm Thread Length | In distribution | |
| 47-4820-014-00 | Length 14 mm | In distribution | |
| 47-4820-016-03 | Length 16 mm | In distribution | |
| 47-4845-040-04 | Length 40 mm | In distribution | |
| 47-4835-014-00 | Length 14 mm | In distribution | |
| 47-4865-075-01 | Length 75 mm | In distribution | |
| 47-4865-090-02 | 6.5 mm, Cancellous Screw, 32 mm Thread Length | In distribution | |
| 28.80.026 | TX10 | In distribution | |
| 47-4865-085-02 | 6.5 mm, Cancellous Screw, 32 mm Thread Length | In distribution | |
| 47-4835-020-04 | 3.5 mm, Shaft Screw | In distribution | |
| 47-4845-032-04 | Length 32 mm | In distribution | |
| 28.01.522 | Length 22 mm | In distribution | |
| 47-4840-022-01 | Length 22 mm | In distribution | |
| 47-4815-006-01 | 1.5 mm, Cortical Screw | In distribution | |
| 519030150 | Outer Diameter 3.9 mm | In distribution | |
| 28.24.150 | TX10 | In distribution | |
| 47-4815-020-01 | 1.5 mm, Cortical Screw | In distribution | |
| 47-4835-038-04 | Length 38 mm | In distribution | |
| 515024070 | TX6 | In distribution | |
| 28.24.134 | Outer Diameter 4.5 mm | In distribution | |
| 28.20.112 | Length 12 mm | In distribution | |
| 519010150 | Outer Diameter 3.9 mm | In distribution | |
| 47-4820-044-02 | 2.0 mm, Cortical Screw | In distribution | |
| 4845-54-01 | Length 54 mm | In distribution | |
| 4865-55-01 | Length 55 mm | In distribution | |
| 35.23.018 | TX6 | In distribution | |
| 47-4815-006-02 | Length 6 mm | In distribution | |
| 35.18.012 | Length 12 mm | In distribution | |
| 4845-100-01 | Length 100 mm | In distribution | |
| 47-4840-014-01 | 4.0 mm, Cancellous Screw | In distribution | |
| 28.20.118 | HEX | In distribution | |
| 47-4820-040-03 | Length 40 mm | In distribution | |
| 47-4820-034-01 | Length 34 mm | In distribution | |
| 4845-44 | Length 44 mm | In distribution | |
| 22.27.609 | Outer Diameter 0.9 mm | 6 | In distribution |
| 47-4820-042-02 | Length 42 mm | In distribution | |
| 47-4865-060-02 | 6.5 mm, Cancellous Screw, 32 mm Thread Length | In distribution | |
| 47-4815-010-01 | 1.5 mm, Cortical Screw | In distribution | |
| 47-4840-080-00 | Length 80 mm | In distribution | |
| 47-4835-030-00 | Length 30 mm | In distribution | |
| 47-4865-075-00 | Length 75 mm | In distribution | |
| 35.23.006 | Outer Diameter 2.3 mm | In distribution | |
| 4865-30-01 | Length 30 mm | In distribution | |
| 519011150 | Outer Diameter 3.9 mm | In distribution | |
| 47-4840-085-01 | 4.0 mm, Cancellous Screw | In distribution | |
| 47-4815-020-02 | Length 20 mm | In distribution | |
| 47-4820-024-02 | 2.0 mm, Cortical Screw | In distribution | |
| 47-4835-010-00 | 3.5 mm, Cortical Screw | In distribution | |
| 28.02.006 | 6mm stem, Sys 3.5 | In distribution | |
| 47-4827-040-00 | Length 40 mm | In distribution | |
| 47-4820-026-03 | 2.0 mm, Cortical Screw | In distribution | |
| 47-4840-090-01 | 4.0 mm, Cancellous Screw | In distribution | |
| 47-4820-036-01 | Length 36 mm | In distribution | |
| 47-4845-022-01 | 4.5 mm, Cortical Screw | In distribution | |
| 47-4840-035-01 | 4.0 mm, Cancellous Screw | In distribution | |
| 47-4840-090-00 | Length 90 mm | In distribution | |
| 47-4820-020-01 | Length 20 mm | In distribution | |
| 4865-55 | Length 55 mm | In distribution | |
| 47-4840-016-01 | 4.0 mm, Cancellous Screw | In distribution | |
| 47-4827-012-00 | Length 12 mm | In distribution | |
| 47-4845-024-01 | Length 24 mm | In distribution | |
| 47-4865-060-00 | Length 60 mm | In distribution | |
| 28.20.036 | HEX | In distribution | |
| 47-4835-022-04 | 3.5 mm, Shaft Screw | In distribution | |
| 47-4820-030-02 | Length 30 mm | In distribution | |
| 35.23.016 | TX6 | In distribution | |
| 519021150 | Outer Diameter 3.9 mm | In distribution | |
| 47-4865-035-01 | Length 35 mm | In distribution | |
| 47-4827-014-00 | 2.7 mm, Cortical Screw | In distribution | |
| 47-4820-020-00 | 2.0 mm, Cortical Screw | In distribution | |
| 605122070 | trocar/trocar | 10 | In distribution |
| 47-4820-018-01 | 2.0 mm, Cortical Screw | In distribution | |
| 47-4820-020-03 | 2.0 mm, Cortical Screw | In distribution | |
| 47-4815-018-00 | 1.5 mm, Cortical Screw | In distribution | |
| 47-4865-085-01 | 6.5 mm, Cancellous Screw, 16 mm Thread Length | In distribution | |
| 28.24.036 | TX10 | In distribution | |
| 4865-100-01 | Length 100 mm | In distribution | |
| 28.80.070 | Length 70 mm | In distribution | |
| 28.20.134 | Outer Diameter 3.5 mm | In distribution | |
| 47-4820-044-00 | Length 44 mm | In distribution | |
| 4845-34-04 | Length 34 mm | In distribution | |
| 28.20.040 | HEX | In distribution | |
| 47-4835-034-00 | 3.5 mm, Cortical Screw | In distribution | |
| 47-4865-095-01 | Length 95 mm | In distribution | |
| 4845-68-01 | 4.5 mm Cortical Screw | In distribution | |
| 47-4815-012-01 | Length 12 mm | In distribution | |
| 47-4840-026-01 | Length 26 mm | In distribution | |
| 47-4845-034-04 | Length 34 mm | In distribution | |
| 4865-50-01 | Length 50 mm | In distribution | |
| 47-4840-018-00 | Length 18 mm | In distribution | |
| 28.04.004 | Length 12 mm | In distribution | |
| 4845-48 | Length 48 mm | In distribution | |
| 47-4840-060-00 | 4.0 mm, Cancellous Screw | In distribution | |
| 47-4815-016-03 | 1.5 mm, Cortical Screw | In distribution | |
| 47-4820-010-03 | Length 10 mm | In distribution | |
| 47-4845-058-01 | Length 58 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MaxTorque™ | Tornier Inc. | 171 |
| Arthrex® | Arthrex, Inc. | 154 |
| Kyocera Medical Technologies, Inc. | Kyocera Medical Technologies, Inc. | 92 |
| Washer, Bolt Nut | Synthes Gmbh | 88 |
| A.l.p.s.® | Biomet Orthopedics | 67 |
| Variax | Stryker GmbH | 59 |
| Conmed | ConMed Corporation | 38 |
| Neoortho | Neoortho Produtos Ortopédicos S/A | 32 |
| Aptus | Medartis Inc. | 31 |
| AC Device | Lockdown Medical Limited | 31 |
| Evos | Smith & Nephew, Inc. | 28 |
| Axis | Extremity Medical, LLC | 26 |
Showing 12 of 304. All products under Washer, Bolt Nut
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K091799 | 2009-09-11 |
Recalls Naming This Product
15 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 Manufacturing B.V. | 510(k) number | 2016-05-04 | Class II | Packaging change control | A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. | 3955 | 2017-07-05 |
| 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. | 154 | 2017-04-13 |
| 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. | 2 | 2017-04-13 |
| 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. | 34 | 2017-04-13 |
| 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. | 83 | 2017-04-13 |
| Zimmer, Inc. | 510(k) number | 2014-07-22 | Class II | Package design/selection | Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only. | 47,682 units total | 2015-06-18 |
| Zimmer, Inc. | 510(k) number | 2014-07-22 | Class II | Package design/selection | Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only. | 47,682 units total | 2015-06-18 |
| Zimmer, Inc. | 510(k) number | 2014-07-22 | Class II | Package design/selection | Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only. | 47,682 units total | 2015-06-18 |
| Zimmer, Inc. | 510(k) number | 2014-07-22 | Class II | Package design/selection | Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only. | 47,682 units total | 2015-06-18 |
| Zimmer, Inc. | 510(k) number | 2014-07-22 | Class II | Package design/selection | Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only. | 47,682 units total | 2015-06-18 |
| Zimmer, Inc. | 510(k) number | 2014-07-22 | Class II | Package design/selection | Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only. | 47,682 units total | 2015-06-18 |
| Zimmer, Inc. | 510(k) number | 2014-07-22 | Class II | Package design/selection | Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only. | 47,682 units total | 2015-06-18 |
| Zimmer, Inc. | 510(k) number | 2014-07-22 | Class II | Package design/selection | Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only. | 47,682 units total | 2015-06-18 |
| Zimmer, Inc. | 510(k) number | 2013-10-11 | Class II | Packaging | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building | 7,044,680 total | 2017-04-14 |
| Zimmer, Inc. | 510(k) number | 2013-10-11 | Class II | Packaging | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building | 7,044,680 total | 2017-04-14 |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2019-10-10 | Class II | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 5459583 total devices | 2020-05-19 |
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.