FDA Medical devices recall ·
LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz recall
- Recall number
- Z-2541-2025
- Date
- (initiated July 31, 2025)
- Company / brand
- Waldemar Link GmbH & Co. KG (Mfg Site)
Oststr. 4-10, Norderstedt, N/A, Germany - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 8 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50
Why was it recalled?
Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
Distribution
Worldwide - US Nationwide distribution in the states of CO, IN, NJ, TX and the countries of Germany and Italy.
States: Colorado Indiana New Jersey Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2541-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.