Endo-Model Replacement Plateau recall (Waldemar Link GmbH & Co. KG (Mfg Site))
Medical deviceClass IIOngoing
Summary: Waldemar Link GmbH & Co. KG (Mfg Site) is recalling Endo-Model Replacement Plateau; Item Number: 15-8521/15;. Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
What is being recalled
Endo-Model Replacement Plateau; Item Number: 15-8521/15;
Why
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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. (states named: New Jersey)
How to tell if yours is affected
Item Number: 15-8521/15; UDI-DI: 04026575383283; Serial/Lot Number: 250805/0020, 250805/0021, 250805/0023, 250805/0024;
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1520-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | January 12, 2026 |
| Reported | March 18, 2026 |
| Company | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Company location | Norderstedt, N/A, Germany |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 4 units (OUS only) |
More recalls from Waldemar Link GmbH & Co. KG (Mfg Site) · all medical device recalls · recalls from January 2026