FDA Device recall Z-1514-2026
Endo-Model SL Connection Component incl
- FDA Device
- Class II
- ongoing
- Published 2026-03-18
On 2026-03-18 the FDA classified a Class II recall of Endo-Model SL Connection Component incl 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-1514-2026 |
| 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 SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
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: 16-2840/07; UDI-DI: 04026575359257; Serial/Lot Number: 250925/0480 , 250925/0481, 250925/0482, 250925/0483…Item Number: 16-2840/07; UDI-DI: 04026575359257; Serial/Lot Number: 250925/0480 , 250925/0481, 250925/0482, 250925/0483, 250925/0484, 250925/0486, 250925/0489 , 250925/0491, 250925/0492, 250925/0494, 250925/0503, 250925/0504, 250925/0345 , 250925/0346, 250925/0349, 250925/0350, 250925/0351, 250925/0352, 250925/0356 , 250925/0369, 250925/0501, 250925/0365, 250925/0368, 250925/0490, 250925/0488 , 250925/0479, 250925/0495, 250925/0500, 250925/0496, 250925/0499, 250925/0367; |
|---|
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-1514-2026%22
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