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U.S. Department of Health and Human Services

Class 2 Device Recall EndoModel, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge

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 Class 2 Device Recall EndoModel, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hingesee related information
Date Initiated by FirmJuly 06, 2026
Date PostedAugust 11, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2934-2026
Recall Event ID 99405
510(K)NumberK143179 
Product Classification Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
ProductEndo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
Code Information UDI-DI 04026575432134 Lot for Implant REF 15-0027/16: 2604069
FEI Number 3003386935
Recalling Firm/
Manufacturer		 Waldemar Link GmbH & Co. KG (Mfg Site)
Ost Str. 4-10
Norderstedt Germany
For Additional Information ContactTerry Sheridan Powell
494053995150
Manufacturer Reason
for Recall		The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted and an alternative product would be needed. If the incorrect plateau were to be implanted, this is associated with increased risk of wear, which could result in a reduced standing time of the implant.
FDA Determined
Cause 2		Process change control
ActionForeign manufacturer, Waldemar Link GmbH & Co KG, notified importer LinkBio Corp. on 7/6/2026 via email. LinkBio then notified the single US consignee by email/Docusign on 7/7/2026. Customer was instructed to return the affected product to LinkBio.
Quantity in Commerce1 US; 9 OUS
DistributionDomestic US distribution to Indiana. OUS distribution to Belarus and Germany.
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 = KRO
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