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U.S. Department of Health and Human Services

Class 2 Device Recall LinkSymphoKnee System

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 Class 2 Device Recall LinkSymphoKnee Systemsee related information
Date Initiated by FirmJuly 31, 2025
Date PostedSeptember 08, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2541-2025
Recall Event ID 97383
510(K)NumberK202924 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductLinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50
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.
Recalling Firm/
Manufacturer		 Waldemar Link GmbH & Co. KG (Mfg Site)
Oststr. 4-10
Norderstedt Germany
For Additional Information ContactJennifer Lubrecht
494053995150
Manufacturer Reason
for Recall		Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
FDA Determined
Cause 2		Under Investigation by firm
ActionWaldemar 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.
Quantity in Commerce8 units
DistributionWorldwide - US Nationwide distribution in the states of CO, IN, NJ, TX and the countries of Germany and Italy.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JWH
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