Endo-Model recall
Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
Why was Endo-Model recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI 04026575432134 Lot for Implant REF 15-0027/16: 2604069
- Product
- Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Quantity
- 1 US; 9 OUS
- Distribution
- Domestic US distribution to Indiana. OUS distribution to Belarus and Germany.
- Recall date
- August 19, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)