Z-2541-2025 Class II Ongoing
FDA device recall Z-2541-2025 was initiated by Waldemar Link GmbH & Co. KG (Mfg Site) on July 31, 2025 and is designated Class II. Reason for recall: Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect. The recall status is ongoing. Affected quantity: 8 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 17, 2025
- Initiation Date
- July 31, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 units
Product Description
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.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of CO, IN, NJ, TX and the countries of Germany and Italy.
Code Information
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.