Endo-Model SL Connection Component incl — Class II medical device recall Z-1511-2026
Ongoing recall by Waldemar Link GmbH & Co. KG (Mfg Site), reported 2026-03-18, distributed nationwide. The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a
| Recall number | Z-1511-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Waldemar Link GmbH & Co. KG (Mfg Site), Norderstedt, N/A, Germany |
| Recall initiated | 2026-01-12 |
| Classified | 2026-03-10 |
| Reported by FDA | 2026-03-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CH, CO, DE, ES, GB, HU, IN, IT, NL, RO, SA |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 04026575359240 |
| Lot numbers | 250513/2083, 250513/2085, 250513/2086, 250513/2087, 250513/2089, 250513/2090, 250513/2091, 250513/2092, 250513/2093, 250513/2097, 250513/2099, 250513/2100, 250513/2102, 250513/2103, 250513/2104, 250513/2105, 250513/2106, 250513/2107, 250513/2108, 251013/3245, 251013/3246, 251013/3247, 251013/3249, 251013/3250, 251013/3251, 251013/3252, 251013/3253, 251013/3254, 251105/0002, 251105/0011, 251105/0012, 251105/0013, 251105/0014, 251105/0016, 251105/0018, 251105/0019, 251105/0020, 251105/0032, 251105/0034, 251105/0036 and 4 more |
| Model numbers | 16-2840/05 |
Product
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1511-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.