FDA DevicesClass II
Endo-Model Replacement Plateau; Item Number: 15-0027/16;
Published: March 18, 2026Recall ID: Z-1523-2026Category: devicesCountry: US
Reason for Recall / Hazard
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Product Description & Identification
Endo-Model Replacement Plateau; Item Number: 15-0027/16;
Affected Products
Endo-Model Replacement Plateau; Item Number: 15-0027/16;
Additional Source Details
| Field | Value |
|---|---|
| City | Norderstedt |
| State | N/A |
| Event id | 98342 |
| Address 1 | Ost Str. 4-10 |
| Address 2 | N/A |
| Code info | Item Number: 15-0027/16; UDI-DI: 04026575432134; Serial/Lot Number: 2550412, 2550413, 2549228; |
| Postal code | N/A |
| Report date | 20260318 |
| Product type | Devices |
| Product quantity | 3 units (OUS only) |
| Reason for recall | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260112 |
| Initial firm notification | Letter |
| Center classification date | 20260310 |
Overview
- Recalling FirmWaldemar Link GmbH & Co. KG (Mfg Site)
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - 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.