Endo-Model recall
Waldemar Link GmbH & Co. KG (Mfg Site) recalled Endo-Model on August 19, 2026 because of the affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. It was sold in IN.
Why it was 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's recalled
Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
Quantity: 1 US; 9 OUS
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Waldemar Link GmbH & Co. KG (Mfg Site), Norderstedt
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- IN
Domestic US distribution to Indiana. OUS distribution to Belarus and Germany. - Status
- Ongoing
- Recall number
- Z-2934-2026
- Source
- U.S. Food and Drug Administration
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