United StatesEndo‑Model Replacement Set, Tibial Plateau, right/left, size L, UHMWPE, CoCrMo, Rotating Hinge (Item Number 15‑0027/16; UDI‑DI 04026575432134; Lot 2604069) distributed in the US (Indiana) and overseas (Belarus, Germany) is affected. The set may incorrectly contain a Pure Hinge plateau that cannot be inserted for a rotating hinge, which could prolong or require modification of surgery and, if implanted, is associated with increased wear and reduced implant standing time.
What's being recalled
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), Norderstedt, Germany.
How to identify it
UDI-DI 04026575432134 Lot for Implant REF 15-0027/16: 2604069
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
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Domestic US distribution to Indiana. OUS distribution to Belarus and Germany.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)