Recall Z-2934-2026
Waldemar Link GmbH & Co. KG (Mfg Site) · initiated July 6, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
Codes / lots: UDI-DI 04026575432134 Lot for Implant REF 15-0027/16: 2604069
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: Process change control
Action taken
Foreign 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.
Details
- Recall number
- Z-2934-2026
- Initiated
- July 6, 2026
- Posted by FDA
- August 11, 2026
- Product code
- KRO – Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
- Quantity
- 1 US; 9 OUS
- Distribution
- Domestic US distribution to Indiana. OUS distribution to Belarus and Germany.
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site), Norderstedt