FDA Device recall Z-1511-2026
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-1511-2026 |
| 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: 16-2840/05;
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: 16-2840/05; UDI-DI: 04026575359240; Serial/Lot Number: 250513/2083, 250513/2085 , 250513/2086, 250513/2089…Item Number: 16-2840/05; UDI-DI: 04026575359240; Serial/Lot Number: 250513/2083, 250513/2085 , 250513/2086, 250513/2089, 250513/2090, 250513/2092, 250513/2093, 250513/2097 , 250513/2100, 250513/2102, 250513/2104, 250513/2107, 250513/2108, 251013/3245 , 251013/3247, 251013/3250, 251013/3251, 251013/3252, 251013/3253, 251105/0013 , 251105/0016, 251105/0018, 251105/0020, 251105/0032, 251105/0034, 251105/0036 , 251105/0037, 251105/0038, 251105/0039, 250513/2106, 250513/2099, 251105/0014 , 251105/0040, 251105/0002, 250513/2087, 250513/2091, 251013/3246, 251105/0019 , 251013/3249, 251105/0011, 251105/0012, 250513/2103, 250513/2105, 251013/3254; |
|---|
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-1511-2026%22
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