Recall Z-2541-2025— Waldemar Link GmbH & Co. KG (Mfg Site)

Name: FDA recall Z-2541-2025
Creator: U.S. Food and Drug Administration
Published: 2025-07-31

Class II · Ongoing

Class II FDA medical device recall by Waldemar Link GmbH & Co. KG (Mfg Site), initiated 2025-07-31. It names one FDA 510(k) clearance: K202924. Product: LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50. Reason: Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect..

Recalling firm: Waldemar Link GmbH & Co. KG (Mfg Site)
Classification: Class II
Status: Ongoing
Initiated: 2025-07-31
Firm location: Norderstedt, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K202924 — LinkSymphoKnee SystemWaldemar Link GmbH & Co. KG·cleared 2021-05-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.