Endo-Model Knee System – Instruments
Catalogue number 16-3211/00, listed by Waldemar Link GmbH & Co. KG, Germany, under Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented. 15 manufacturers in China are registered for this product code.
15manufacturers in China registered for this device type
1catalogue number
11510(k) clearances naming this product code
15recalls on this code
Who Else Makes It
Concentrated in Jiangsu (8), Shanghai (3), Zhejiang (2). 10 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 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| Lincotek (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 7 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 15. All 15 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Record
| Listed by | Waldemar Link GmbH & Co. KG, Germany |
|---|---|
| FDA product code | LZO |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3353 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K151008 |
| Record published | 2023-04-27 |
| Record revised | 2024-01-08 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 16-3211/00 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Libertas | Maxx Orthopedics Inc. | 1,832 |
| Redapt | Smith & Nephew, Inc. | 326 |
| Bencox Hip System | Corentec Co., Ltd. | 295 |
| M-Vizion Femoral Revision System | Medacta International SA | 289 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Zimmer, Inc. | 280 |
| Profemur® | Microport Orthopedics Inc. | 229 |
| DJO Surgical | Encore Medical, L.P. | 162 |
| Instrument | Howmedica Osteonics Corp | 152 |
| Alteon | Exactech, Inc. | 151 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Exactech, Inc. | 136 |
| Resolve Modular Revision Hip Stem | United Orthopedic Corp. | 136 |
| Wagner SL Revision® | Zimmer, Inc. | 133 |
Showing 12 of 691. All products under Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261009 | 2026-07-06 |
| K243927 | 2025-05-16 |
| K213770 | 2022-09-13 |
| K211567 | 2022-06-03 |
| K213675 | 2022-04-11 |
| K192559 | 2019-12-21 |
| K190535 | 2019-08-06 |
| K182321 | 2019-05-24 |
| K183141 | 2019-02-08 |
| K161840 | 2017-03-16 |
| K142187 | 2014-11-06 |
Recalls Naming This Product
14 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 |
|---|---|---|---|---|---|---|
| Waldemar Link GmbH & Co. KG | 510(k) number | 2026-01-12 | Class II | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | 44 units (1 US, 43 OUS) |
| Waldemar Link GmbH & Co. KG | 510(k) number | 2026-01-12 | Class II | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | 3 units |
| Waldemar Link GmbH & Co. KG | 510(k) number | 2026-01-12 | Class II | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | 49 units (OUS only) |
| Waldemar Link GmbH & Co. KG | 510(k) number | 2026-01-12 | Class II | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | 31 units (OUS only) |
| Waldemar Link GmbH & Co. KG | 510(k) number | 2026-01-12 | Class II | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | 1 unit (OUS only) |
| Waldemar Link GmbH & Co. KG | 510(k) number | 2026-01-12 | Class II | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | 7 units (OUS only) |
| Waldemar Link GmbH & Co. KG | 510(k) number | 2026-01-12 | Class II | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | 4 units (all OUS) |
| Waldemar Link GmbH & Co. KG | 510(k) number | 2026-01-12 | Class II | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | 8 units (OUS only) |
| Waldemar Link GmbH & Co. KG | 510(k) number | 2026-01-12 | Class II | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | 7 units (OUS only) |
| Waldemar Link GmbH & Co. KG | 510(k) number | 2026-01-12 | Class II | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | 4 units (OUS only) |
| Waldemar Link GmbH & Co. KG | 510(k) number | 2026-01-12 | Class II | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | 2 units (OUS only) |
| Waldemar Link GmbH & Co. KG | 510(k) number | 2026-01-12 | Class II | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | 1 unit (OUS only) |
| Waldemar Link GmbH & Co. KG | 510(k) number | 2026-01-12 | Class II | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | 3 units (OUS only) |
| Waldemar Link GmbH & Co. KG | 510(k) number | 2025-11-10 | Class II | Process control | The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component. | 18 units |
Recalls
15 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 |
|---|---|---|---|---|---|
| 2024-12-05 | Class II | Under Investigation by firm | Error on the main label and the patient label. The labels indicate a size XXL, this is a standard-size neck segment.. All further information on the labels is correct (Length, CCD and Offset). | 3 units | |
| 2024-01-22 | Class II | Under Investigation by firm | Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery | ||
| 2023-07-03 | Class II | Device Design | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm – 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue | 24 units | |
| 2023-07-03 | Class II | Device Design | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm – 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue | 24 units | |
| 2023-07-03 | Class II | Device Design | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm – 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue | 24 units | |
| 2023-07-03 | Class II | Device Design | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm – 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue | 24 units | |
| 2023-07-03 | Class II | Device Design | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm – 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue | 24 units | |
| 2023-07-03 | Class II | Device Design | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm – 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue | 24 units | |
| 2023-07-03 | Class II | Device Design | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm – 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue | 24 units | |
| 2023-07-03 | Class II | Device Design | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm – 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue | 14 units | |
| 2023-07-03 | Class II | Device Design | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm – 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue | 24 units | |
| 2023-07-03 | Class II | Device Design | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm – 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue | 24 units | |
| 2023-07-03 | Class II | Device Design | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm – 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue | 24 units | |
| 2023-07-03 | Class II | Device Design | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm – 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue | 24 units | |
| 2018-12-07 | Class II | Under Investigation by firm | The reaming guide and the guide rod can’t be screwed into the intended depth. The reason for this is a reduced depth of the core hole in the stem. A reaming guide that is not screwed in completely may lead to a proximal preparation in the d | 11 | 2019-12-17 |
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.