Endo-Model Replacement Plateau; Item Number: 15-2835/12;
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | January 12, 2026 |
| Reported | March 18, 2026 |
| Recalling firm | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Country / region | Germany N/A |
Hazard
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Affected products
- Endo-Model Replacement Plateau; Item Number: 15-2835/12;
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