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Endo-Model Modular Knee Prosthesis System
WALDEMAR LINK GmbH & Co. KG · Model 15-2962/11 · UDI-DI 04026575214136
1
510(k) clearances
4,170
Adverse events (13 deaths)
26
Recalls
159
Facilities
Description
Femoral Segment
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-12-01 | Howmedica Osteonics Corp. | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material pr |
| 2023-12-01 | Howmedica Osteonics Corp. | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material pr |
| 2020-07-31 | MicroPort Orthopedics Inc. | MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra-long Titanium modular femoral neck component after implantation. Worldwide there |
| 2020-07-31 | MicroPort Orthopedics Inc. | MicroPort Orthopedics Inc. is voluntarily recalling any existing inventory of PROFEMUR Titanium and Cobalt Chrome modular necks with previous package insert versions to replace the |
| 2020-07-31 | MicroPort Orthopedics Inc. | MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra-long Titanium modular femoral neck component after implantation. Worldwide there |
| 2016-06-30 | MicroPort Orthopedics Inc. | Profemur(R) neck, Item Number PHA01222 (Short AR VV2 Ti Neck) was labeled as Item Number PHA01212 (Short AR VV1 Ti Neck). |
| 2013-10-11 | Zimmer, Inc. | 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 determ |
| 2009-06-18 | Stryker Howmedica Osteonics Corp. | Sterilization issue: During post-sterilization inspection of the outer blister packaging of the affected lots, it was determined that the outer blister did not meet the required mi |
| 2009-05-15 | Zimmer Inc. | The threads on the screw are incomplete/non-functional. |
| 2008-10-31 | Stelkast Co | A possible breach of the sterile barrier packaging (Tyvek pouch). |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.