LinkSymphoKnee System — Class II medical device recall Z-2541-2025
Ongoing recall by Waldemar Link GmbH & Co. KG (Mfg Site), reported 2025-09-17, distributed nationwide. Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which
| Recall number | Z-2541-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Waldemar Link GmbH & Co. KG (Mfg Site), Norderstedt, N/A, Germany |
| Recall initiated | 2025-07-31 |
| Classified | 2025-09-08 |
| Reported by FDA | 2025-09-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, IT |
| Quantity | 8 units |
| UPC / GTIN / UDI-DI | 04026575251278 |
| Serial numbers | 210125/2259, 210125/2260, 210125/2262, 210125/2264, 210125/2268, 210125/2270, 210125/2272, 210125/2273 |
| Model numbers | 880-100/50 |
Product
LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50
Reason for recall
Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2541-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.