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Endo-Model Standard Knee Prosthesis System
WALDEMAR LINK GmbH & Co. KG · Model 15-2519/29 · UDI-DI 04026575204236
KRO
Prescription
10
510(k) clearances
9,364
Adverse events (54 deaths)
123
Recalls
133
Facilities
Description
Proximal Tibial Spacer,Set Size large, consisting of 5, 10 and 15 mm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-06 | Waldemar Link GmbH & Co. KG (Mfg Site) | The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified s |
| 2026-05-20 | United Orthopedic Corp. | Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. |
| 2026-05-19 | DEPUY (IRELAND) | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. |
| 2026-05-19 | DEPUY (IRELAND) | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. |
| 2026-04-03 | DEPUY (IRELAND) | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. |
| 2026-04-03 | DEPUY (IRELAND) | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. |
| 2026-04-03 | DEPUY (IRELAND) | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. |
| 2026-04-03 | DEPUY (IRELAND) | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. |
| 2026-04-03 | DEPUY (IRELAND) | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. |
| 2026-04-03 | DEPUY (IRELAND) | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. |
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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.