FDAHealthJanuary 12, 2026
Waldemar Link GmbH & Co. KG (Mfg Site) — Endo-Model Replacement Plateau; Item Number: 15-2835/12;
⚠️ The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- January 12, 2026
Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.
What's affected?
- Product
- Endo-Model Replacement Plateau; Item Number: 15-2835/12;
- Lot code
- 241210/1809
Additional details
Item Number: 15-2835/12; UDI-DI: 04026575316564; Serial/Lot Number: 241210/1809;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1 unit (OUS only).
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