LINK MP Reconstruction System Neck Segment — Class II medical device recall Z-0769-2025
Ongoing recall by Waldemar Link GmbH & Co. KG (Mfg Site), reported 2025-01-01, distributed nationwide. Error on the main label and the patient label. The labels indicate a size XXL, this is a standard-size neck se
| Recall number | Z-0769-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Waldemar Link GmbH & Co. KG (Mfg Site), Norderstedt, Germany |
| Recall initiated | 2024-12-05 |
| Classified | 2024-12-26 |
| Reported by FDA | 2025-01-01 |
| Distributed | Nationwide (US) |
| Quantity | 3 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 04026575409785 |
| Serial numbers | 170418/1971, 170515/1335, 170717/1773, 180219/1681, 180219/1687, 211122/0489, 231113/2462, 231113/2463, 231113/2464, 231113/2465, 231113/2466, 231113/2467, 231113/2468, 231113/2469, 231113/2470, 231113/2472, 231113/2473, 231113/2474, 231113/2475, 231113/2476, 231113/2478, 231113/2479, 240219/0505, 240219/0506, 240219/0507 and 34 more |
| Model numbers | 99-0984/32 |
Product
LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126¿, Offset= 31 mm, Ti6Al4V, PoroLink, Taper 12/14. Item Number: 99-0984/32 Intended for revision hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal femur.
Reason for recall
Error on the main label and the patient label. The labels indicate a size XXL, this is a standard-size neck segment.. All further information on the labels is correct (Length, CCD and Offset).
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-0769-2025. 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.