Safety Alert: Class II: Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
healthClass IIRecalled on Sep 17, 2025
LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50
🔢 8 units
Sold At: Waldemar Link GmbH & Co. KG (Mfg Site)(Worldwide - US Nationwide distribution in the states of CO, IN, NJ, TX and the countries of Germany and Italy.)
Recall #: FDA-DEVICE-Z-2541-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- REF Number: 880-100/50. UDI-DI: 04026575251278. Serial Numbers: 210125/2259, 210125/2262, 210125/2268, 210125/2260, 210125/2264, 210125/2270, 210125/2272, 210125/2273.
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Summary
Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
What to do next
- 1Stop using this product - may cause temporary or medically reversible health problems
- 2Check with retailer or manufacturer for recall status and remedy options
- 3Contact Waldemar Link GmbH & Co. KG (Mfg Site) for return or refund information
- 4Visit the official FDA recall page for complete details
Summaries only; always follow the official notice.