FDAFDA · Food and drugs·Recall number Z-2934-2026
Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
Published August 19, 2026 · Recall initiated: July 6, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Distributor
- Domestic US distribution to Indiana. OUS distribution to Belarus and Germany.
- Lot
- UDI-DI 04026575432134 Lot for Implant REF 15-0027/16: 2604069
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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