DJO Surgical
FOUNDATION® KNEE SYSTEM Distal Femoral Revision Spacer Blocks 5mm
21manufacturers in China registered for this device type
1,131catalogue numbers in this listing
15510(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 | Encore Medical, L.P., 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, Complaint-file establishment, Manufacturer |
| 510(k) | K170573 |
| Record published | 2017-06-01 |
| Record revised | 2023-02-03 (version 9) |
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 |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2015-09-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 801-05-819 | In distribution | |
| 360-15-508 | In distribution | |
| 344-16-711 | In distribution | |
| 210-05-112 | In distribution | |
| 391-15-604 | In distribution | |
| 346-10-705 | In distribution | |
| 130-03-026 | In distribution | |
| 343-14-766 | In distribution | |
| 391-13-608 | In distribution | |
| 334-01-110 | In distribution | |
| 391-11-604 | In distribution | |
| 220-10-022 | In distribution | |
| 385-09-502 | In distribution | |
| 391-11-602 | In distribution | |
| 356-02-002 | In distribution | |
| 346-25-101 | In distribution | |
| 344-12-703 | In distribution | |
| 391-19-602 | In distribution | |
| 800-05-152 | In distribution | |
| 391-13-606 | In distribution | |
| 392-11-702 | In distribution | |
| 202-01-106 | In distribution | |
| 292-21-706 | In distribution | |
| 352-00-102 | In distribution | |
| 356-01-004 | In distribution | |
| 385-15-502 | In distribution | |
| 391-09-606 | In distribution | |
| 110-02-035 | In distribution | |
| 391-19-606 | In distribution | |
| 320-10-014 | In distribution | |
| 212-02-105 | In distribution | |
| 292-15-002 | In distribution | |
| 212-02-107 | In distribution | |
| 370-25-508 | In distribution | |
| 352-03-109 | In distribution | |
| 214-01-002 | In distribution | |
| 324-01-102 | In distribution | |
| 344-10-708 | In distribution | |
| 322-10-106 | In distribution | |
| 321-05-102 | In distribution | |
| 360-13-510 | In distribution | |
| 354-12-065 | In distribution | |
| 391-19-708 | In distribution | |
| 245-02-109 | In distribution | |
| 282-03-106 | In distribution | |
| 800-05-108 | In distribution | |
| 343-14-711 | In distribution | |
| 391-13-607 | In distribution | |
| 352-01-107 | In distribution | |
| 800-05-107 | In distribution | |
| 385-09-504 | In distribution | |
| 315-0A-719 | In distribution | |
| 391-15-610 | In distribution | |
| 200-05-002 | In distribution | |
| 242-01-107 | In distribution | |
| 200-05-006 | In distribution | |
| 345-11-707 | In distribution | |
| 343-12-708 | In distribution | |
| 282-03-110 | In distribution | |
| 245-05-089 | In distribution | |
| 352-04-110 | In distribution | |
| 800-05-157 | In distribution | |
| 385-11-506 | In distribution | |
| 343-16-708 | In distribution | |
| 220-10-016 | In distribution | |
| 391-09-603 | In distribution | |
| 120-01-029 | In distribution | |
| 341-11-705 | In distribution | |
| 801-05-800 | In distribution | |
| 292-13-210 | In distribution | |
| 352-00-105 | In distribution | |
| 346-16-711 | In distribution | |
| 801-05-778 | In distribution | |
| 282-01-110 | In distribution | |
| 801-05-807 | In distribution | |
| 341-13-706 | In distribution | |
| 352-02-103 | In distribution | |
| 392-09-607 | In distribution | |
| 346-19-704 | In distribution | |
| 348-10-707 | In distribution | |
| 202-01-104 | In distribution | |
| 370-22-502 | In distribution | |
| 214-09-005 | In distribution | |
| 210-10-108 | In distribution | |
| 344-13-707 | In distribution | |
| 800-05-080 | In distribution | |
| 344-16-709 | In distribution | |
| 801-05-762 | In distribution | |
| 323-01-108 | In distribution | |
| 392-11-608 | In distribution | |
| 346-10-703 | In distribution | |
| 210-10-004 | In distribution | |
| 801-05-537 | In distribution | |
| 213-08-003 | In distribution | |
| 800-05-135 | In distribution | |
| 800-05-121 | In distribution | |
| 801-05-796 | In distribution | |
| 346-10-100 | In distribution | |
| 348-10-703 | In distribution | |
| 315-0D-317 | In distribution | |
| 315-0B-712 | In distribution | |
| 211-02-112 | In distribution | |
| 370-22-508 | In distribution | |
| 343-10-709 | In distribution | |
| 290-01-002 | In distribution | |
| 343-10-766 | In distribution | |
| 336-01-112 | In distribution | |
| 321-10-101 | In distribution | |
| 346-10-704 | In distribution | |
| 370-13-510 | In distribution | |
| 801-05-812 | In distribution | |
| 802-05-104 | In distribution | |
| 345-11-705 | In distribution | |
| 801-05-781 | In distribution | |
| 150-01-032 | In distribution | |
| 391-09-607 | In distribution | |
| 292-11-210 | In distribution | |
| 292-13-006 | In distribution | |
| 352-03-110 | In distribution | |
| 346-19-101 | In distribution | |
| 214-01-012 | In distribution | |
| 344-12-707 | In distribution | |
| 322-05-104 | In distribution | |
| 344-19-705 | In distribution | |
| 356-01-002 | In distribution | |
| 213-01-006 | In distribution | |
| 215-12-040 | In distribution | |
| 345-13-708 | In distribution | |
| 214-01-006 | In distribution | |
| 800-05-104 | In distribution | |
| 211-02-104 | In distribution | |
| 391-11-608 | In distribution | |
| 205-01-004 | In distribution | |
| 380-19-512 | In distribution | |
| 391-09-604 | In distribution | |
| 321-05-108 | In distribution | |
| 292-11-004 | In distribution | |
| 346-14-100 | In distribution | |
| 214-09-003 | In distribution | |
| 348-19-705 | In distribution | |
| 801-05-773 | In distribution | |
| 292-15-710 | In distribution | |
| 211-02-108 | In distribution | |
| 391-09-608 | In distribution | |
| 801-05-743 | In distribution | |
| 391-19-610 | In distribution | |
| 348-12-708 | In distribution | |
| 220-15-018 | In distribution | |
| 392-11-706 | In distribution | |
| 311-02-112 | In distribution | |
| 360-13-504 | In distribution | |
| 220-10-018 | In distribution | |
| 245-01-111 | In distribution | |
| 120-01-038 | In distribution | |
| 800-05-137 | In distribution | |
| 345-19-708 | In distribution | |
| 801-05-737 | In distribution | |
| 348-10-755 | In distribution | |
| 282-01-102 | In distribution | |
| 380-15-512 | In distribution | |
| 801-05-775 | In distribution | |
| 213-08-008 | In distribution | |
| 360-13-502 | In distribution | |
| 345-11-706 | In distribution | |
| 344-11-711 | In distribution | |
| 360-09-512 | In distribution | |
| 352-00-104 | In distribution | |
| 212-02-102 | In distribution | |
| 215-0A-005 | In distribution | |
| 800-05-159 | In distribution | |
| 315-0A-717 | In distribution | |
| 801-05-707 | In distribution | |
| 214-01-004 | In distribution | |
| 336-02-108 | In distribution | |
| 801-05-764 | In distribution | |
| 130-10-738 | In distribution | |
| 346-22-707 | In distribution | |
| 343-11-706 | In distribution | |
| 352-01-110 | In distribution | |
| 801-05-729 | In distribution | |
| 354-15-025 | In distribution | |
| 385-19-506 | In distribution | |
| 281-01-110 | In distribution | |
| 210-10-106 | In distribution | |
| 282-03-112 | In distribution | |
| 800-05-109 | In distribution | |
| 281-03-112 | In distribution | |
| 321-05-101 | In distribution | |
| 343-13-708 | In distribution | |
| 391-11-003 | In distribution | |
| 385-09-510 | In distribution | |
| 220-10-110 | In distribution | |
| 245-01-107 | In distribution | |
| 800-05-110 | In distribution | |
| 201-01-105 | In distribution | |
| 385-19-512 | In distribution | |
| 360-09-510 | In distribution | |
| 348-22-755 | In distribution | |
| 290-02-004 | In distribution | |
| 800-05-145 | In distribution | |
| 206-01-012 | In distribution | |
| 380-11-502 | In distribution | |
| 385-15-504 | In distribution | |
| 348-25-777 | In distribution | |
| 210-05-102 | In distribution | |
| 242-01-106 | In distribution | |
| 202-01-105 | In distribution | |
| 315-10-00A | In distribution | |
| 800-05-118 | In distribution | |
| 801-05-804 | In distribution | |
| 392-19-707 | In distribution | |
| 245-05-167 | In distribution | |
| 370-17-512 | In distribution | |
| 348-25-706 | In distribution | |
| 292-18-004 | In distribution | |
| 312-02-106 | In distribution | |
| 352-00-112 | In distribution | |
| 315-0D-714 | In distribution | |
| 352-03-111 | In distribution | |
| 345-14-702 | In distribution | |
| 322-05-102 | In distribution | |
| 210-10-012 | In distribution | |
| 370-22-512 | In distribution | |
| 392-15-007 | In distribution | |
| 245-05-111 | In distribution | |
| 800-05-156 | In distribution | |
| 245-01-103 | In distribution | |
| 391-19-005 | In distribution | |
| 348-19-702 | In distribution | |
| 341-11-704 | In distribution | |
| 201-01-107 | In distribution | |
| 292-13-706 | In distribution | |
| 311-02-102 | In distribution | |
| 391-15-710 | In distribution | |
| 800-05-160 | In distribution | |
| 356-01-003 | In distribution | |
| 352-00-108 | In distribution | |
| 391-15-608 | In distribution | |
| 120-01-732 | In distribution | |
| 160-10-735 | In distribution | |
| 245-01-106 | In distribution | |
| 130-03-032 | In distribution | |
| 380-19-510 | In distribution | |
| 343-10-703 | In distribution | |
| 343-11-709 | In distribution | |
| 348-25-704 | In distribution | |
| 370-15-504 | In distribution | |
| 345-19-706 | In distribution | |
| 343-14-706 | In distribution | |
| 360-09-502 | In distribution |
Showing 250 of 300 catalogue numbers.
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 |
| 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 |
| Truliant® | Exactech, Inc. | 934 |
Showing 12 of 1,175. All products under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252974 | 2025-12-19 |
| K251776 | 2025-07-08 |
| K251241 | 2025-07-02 |
| K213793 | 2022-04-01 |
| K180930 | 2018-07-09 |
| K173723 | 2018-03-05 |
| K170573 | 2017-05-31 |
| K161945 | 2016-09-23 |
| K160342 | 2016-05-19 |
| K143242 | 2015-05-15 |
| K140830 | 2014-07-11 |
| K122239 | 2013-04-11 |
| K121835 | 2012-07-20 |
| K100900 | 2010-06-18 |
| K063406 | 2007-01-08 |
Recalls Naming This Product
45 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Encore Medical, L.P. | 510(k) number | 2026-02-16 | Class II | Process change control | Due to packaging discrepancy with incorrect product size mixed up. | 4 | |
| Encore Medical, L.P. | 510(k) number | 2026-02-16 | Class II | Process change control | Due to packaging discrepancy with incorrect product size mixed up. | 8 | |
| Encore Medical, L.P. | 510(k) number | 2026-01-15 | Class II | Process control | Knee and Humeral socket implants contain incorrect labeling. | 14 implants | |
| Encore Medical, L.P. | 510(k) number | 2026-01-05 | Class II | Labeling Change Control | 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices o | 19 | |
| Encore Medical, L.P. | 510(k) number | 2025-07-09 | Class II | Labeling Change Control | Knee implants contain incorrect labeling (size and/or side incorrect) | 18 implants | |
| Encore Medical, L.P. | 510(k) number | 2025-07-09 | Class II | Labeling Change Control | Knee implants contain incorrect labeling (size and/or side incorrect) | 40 implants | |
| Encore Medical, L.P. | 510(k) number | 2025-06-02 | Class II | Packaging change control | Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used. | 20 | |
| Encore Medical, L.P. | 510(k) number | 2025-06-02 | Class II | Packaging change control | Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used. | 20 | |
| Encore Medical, L.P. | 510(k) number | 2024-12-18 | Class II | Labeling Change Control | 5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which may cause surgical delay to get a new product. | 33 | |
| Encore Medical, L.P. | 510(k) number | 2024-12-10 | Class II | Labeling Change Control | Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product. | 9 | |
| Encore Medical, L.P. | UDI-DI | 2023-10-05 | Class II | Packaging process control | Mislabeling | 2 units | |
| Encore Medical, L.P. | 510(k) number | 2023-08-22 | Class II | Labeling Change Control | Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee) | 36 | |
| Encore Medical, L.P. | 510(k) number | 2023-08-04 | Class II | Nonconforming Material/Component | Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery | 20 | |
| Encore Medical, L.P. | 510(k) number | 2023-02-28 | Class II | Process change control | Patella drills are marked with incorrect diameter size of 5.6mm, when they should be 5.4mm. Porous patella overdrills are marked with incorrect diameter size of 5.4 mm, when they should be 5.6 mm. If the incorrect drill is selected during s | 29 | |
| Encore Medical, L.P. | 510(k) number | 2022-12-22 | Class II | Labeling Change Control | Tibial insert implant large boxes were labeled small and the small boxes were labeled large. If the incorrect labeling is identified this could lead to surgical delay and if the surgeon does not recognize the size discrepancy between the in | 216 | |
| Encore Medical, L.P. | 510(k) number | 2022-05-05 | Class II | Labeling mix-ups | A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial insert. If implanted, a risk may include leaving debris in the joint space. | 20 | |
| Encore Medical, L.P. | 510(k) number | 2021-05-12 | Class II | Mixed-up of materials/components | Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains 16mm knee prosthesis and 16mm knee prosthesis packaging contains 12 mm knee prosthesis. | 10 units | |
| Encore Medical, L.P. | 510(k) number | 2021-05-12 | Class II | Mixed-up of materials/components | Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains 16mm knee prosthesis and 16mm knee prosthesis packaging contains 12 mm knee prosthesis. | 10 units | |
| Encore Medical, L.P. | 510(k) number | 2021-02-05 | Class II | Nonconforming Material/Component | Incorrect assembly of a subcomponent by a vendor and as a result, the windows provided to show the size are facing the opposite direction. | 16 units | |
| Encore Medical, L.P. | 510(k) number | 2017-12-12 | Class II | Device Design | The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended. | 2 units | 2022-06-13 |
| Encore Medical, L.P. | 510(k) number | 2017-12-12 | Class II | Device Design | The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended. | 2 units | 2022-06-13 |
| Encore Medical, L.P. | 510(k) number | 2017-12-12 | Class II | Device Design | The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended. | 2 units | 2022-06-13 |
| Encore Medical, L.P. | 510(k) number | 2017-12-12 | Class II | Device Design | The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended. | 2 units | 2022-06-13 |
| Encore Medical, L.P. | 510(k) number | 2017-09-15 | Class II | Packaging process control | It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707. | 48 units | 2023-08-29 |
| Encore Medical, L.P. | 510(k) number | 2017-09-15 | Class II | Packaging process control | It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707. | 46 units | 2023-08-29 |
| Encore Medical, L.P. | 510(k) number | 2017-05-31 | Class II | Packaging process control | Mis-pack. A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibial Insert. | 9 units | 2021-01-08 |
| Encore Medical, L.P. | 510(k) number | 2017-05-31 | Class II | Packaging process control | Mis-pack. A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibial Insert. | 9 units | 2021-01-08 |
| Encore Medical, L.P. | 510(k) number | 2017-01-10 | Class II | Component design/selection | The Empowr PS Insert was reported as missing the impaction slot feature. | 24 units | 2017-05-11 |
| Encore Medical, L.P. | 510(k) number | 2016-11-15 | Class II | Mixed-up of materials/components | A size 4 Empowr baseplate was mislabeled as a size 6. The affected lot was laser marked as M6, marked with the lot number for the size 6 minus lot, and distributed as size 6 minus. | 7 units | 2017-01-20 |
| Encore Medical, L.P. | 510(k) number | 2016-09-19 | Class II | Under Investigation by firm | It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery. The current design of the captured box cut guides can create an instance where | 436 units | 2017-10-20 |
| Encore Medical, L.P. | 510(k) number | 2016-09-19 | Class II | Device Design | It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery. | 162 units | 2017-10-20 |
| Encore Medical, L.P. | 510(k) number | 2015-09-16 | Class II | Labeling design | The labeling is missing the size/diameter information. | 209 units | 2016-01-04 |
| Encore Medical, L.P. | 510(k) number | 2013-04-01 | Class II | Labeling mix-ups | U.S. Agent contacted Director Commercial Logistics, notifying him of incorrect color coded labels on two packages of e+tibial inserts. There were 8 e+ tibial inserts of the same lot number in Finished Goods as the two from the agency. Thes | 5 | 2013-07-01 |
| Encore Medical, L.P. | 510(k) number | 2012-08-09 | Class II | Incorrect or no expiration date | The firm is recalling one lot of 392-09-706, 3DKnee e+ Tibial insert, 9 mm, Size 6, Right. The shelf life labeling of specific lots for a component were found to be incorrect and were found to be expired. | 7 units | 2013-01-25 |
| Encore Medical, L.P. | 510(k) number | 2011-10-26 | Not classified | Nonconforming Material/Component | The strike plate may dislodge from the broach stem handle during impaction of the device. | 30 units | 2012-09-05 |
| Encore Medical, L.P. | 510(k) number | 2010-06-28 | Not classified | Labeling mix-ups | One lot of product has an incorrect color label. The color label is a secondary visual indicator of sizing. | 18 | 2010-10-04 |
| Encore Medical, L.P. | 510(k) number | 2010-03-19 | Not classified | Packaging process control | Affected product had incorrect color label which is a secondary visual indicator for sizing. | 7 units | 2010-07-22 |
| Encore Medical, L.P. | 510(k) number | 2010-02-22 | Not classified | Process control | One lot of product was incorrectly manufactured. Pegs are larger than specification. | 2 units | 2010-07-22 |
| Encore Medical, L.P. | 510(k) number | 2008-08-04 | Not classified | Device Design | Complaints received regarding the fracture of the Nitronic 60 screw on the Tibial Fixed Impactor during surgery. | 68 units. | 2009-08-03 |
| Encore Medical, L.P. | 510(k) number | 2008-02-20 | Not classified | Error in labeling | Tibial insert trial incorrectly marked for thickness; device thickness marked correctly as 13mm on the underside of the trial, but is incorrectly marked as 15mm on the side. | 6 units. | 2008-09-02 |
Showing 40 of 45.
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. 1 is recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-05-14 | Class II | No Marketing Application | After receipt of a product complaint for the labeling, it was determined that this device does not have FDA clearance. | 12 | 2020-08-17 |
| 2009-12-11 | Not classified | Process control | Partial lot of product was not manufactured to specification. Central locking screw was missing threads. There is a potential for dissociation because the screw is not able to be used as a secondary fixation method. | 17 | 2010-09-24 |
| 2009-12-03 | Not classified | Mixed-up of materials/components | Product does not meet specifications for a size 8 Right Foundation Tibia Baseplate. | 17 | 2010-05-05 |
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.