Waldemar Link GmbH & Co. KG (Mfg Site) — Endo-Model Replacement Plateau; Item Number: 15-2836/11;
⚠️ 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: 15-2836/11;
- Lot code
- 250623/3643
Additional details
Item Number: 15-2836/11; UDI-DI: 04026575316571; Serial/Lot Number: 250623/3643, 250623/3644, 250623/3645, 250623/3646, 250623/3648, 250812/2812, 250812/2811;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 7 units (OUS only).
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