Endo-Model Replacement Plateau — Class II medical device recall Z-1518-2026
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-1518-2026 |
|---|---|
| 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 |
| Quantity | 8 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 04026575383238 |
| Lot numbers | 250728/0038, 250728/0039, 250728/0040, 250728/0041, 250728/0042, 250728/0043, 250728/0044, 250728/0045 |
| Model numbers | 15-8521/09 |
Product
Endo-Model Replacement Plateau; Item Number: 15-8521/09;
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-1518-2026. 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.