FDA Device recall Z-1516-2026
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-1516-2026 |
| 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: 15-2836/11;
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: 15-2836/11; UDI-DI: 04026575316571; Serial/Lot Number: 250623/3643, 250623/3644, 250623/3645, 250623/3646, 250623/3648, 250812/2812, 250812/2811; |
|---|
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-1516-2026%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.