LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50
This recall is currently active, issued September 8, 2025. It was issued by Waldemar Link Gmbh & Co. Kg (Mfg Site) Oststr. 4-10 Norderstedt Germany.
- Recall Initiated
- July 31, 2025
- Posted
- September 8, 2025
- Recall Number
- Z-2541-2025
- Quantity
- 8 units
- Official Source
- View on FDA website ↗
Reason for Recall
Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
Distribution
Worldwide - US Nationwide distribution in the states of CO, IN, NJ, TX and the countries of Germany and Italy.
Lot / Code Info
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.
Root Cause
Under Investigation by firm
Action Taken
Waldemar Link notified consignees on about 07/31/2025 via URGENT: MEDCICAL DEVICE RECALL letter. Consignees were instructed to identify any affected units and arranging for their return to LinkBio Corporation, and to also complete and return the response form.