FDA Device recall Z-1523-2026
Endo-Model Replacement Plateau
- FDA Device
- Class II
- ongoing
- Published 2026-03-18
On 2026-03-18 the FDA classified a Class II recall of Endo-Model Replacement Plateau by Waldemar Link And Kg Mfg Site, citing the potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1523-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-01-12 |
| Published | 2026-03-18 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Waldemar Link And Kg Mfg Site |
| Distribution | US |
Product
Endo-Model Replacement Plateau; Item Number: 15-0027/16;
Reason
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Identifiers
| code_info | Item Number: 15-0027/16; UDI-DI: 04026575432134; Serial/Lot Number: 2550412, 2550413, 2549228; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1523-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.