Endo-Model SL Connection Component incl — Class II medical device recall Z-1513-2026
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-1513-2026 |
|---|---|
| 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 | 49 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 04026575359233 |
| Lot numbers | 250925/0639, 250925/0640, 250925/0641, 250925/0642, 250925/0644, 250925/0646, 250925/0648, 250925/0650, 250925/0651, 250925/0652, 250925/0653, 250925/0656, 250925/0657, 250925/0658, 250925/0659, 250925/0660, 250925/0661, 250925/0663, 250925/0664, 250925/0665, 250925/0668, 250925/0669, 250925/0670, 250925/0671, 250925/0673, 250925/0674, 250925/0676, 250925/0678, 250925/0680, 250925/0681, 250925/0682, 250925/0683, 250925/0684, 250925/0685, 250925/0687, 250925/0688, 250925/0689, 250925/0690, 250925/0691, 250925/0693 and 9 more |
| Model numbers | 16-2840/02 |
Product
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
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-1513-2026. 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.