SPII Model Lubinus — Class II medical device recall Z-1297-2024
Ongoing recall by Waldemar Link GmbH & Co. KG (Mfg Site), reported 2024-03-20, distributed nationwide. Due to two complaints, has come to our attention that additional guidance is required on the correct interpret
| Recall number | Z-1297-2024 |
|---|---|
| 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 | 2024-02-06 |
| Classified | 2024-03-14 |
| Reported by FDA | 2024-03-20 |
| Distributed | Nationwide (US) |
| Quantity | 34 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 04026575241347, 04026575241354, 04026575241361, 04026575241378, 04026575241385, 04026575241392, 04026575241408, 04026575241415, 04026575241422, 04026575241439, 04026575241446, 04026575241453, 04026575241460, 04026575241477, 04026575241484, 04026575241491, 04026575241507, 04026575241514, 04026575241521, 04026575241538, 04026575241545, 04026575241552, 04026575241569, 04026575241576, 04026575241583 and 31 more |
Product
SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented
Reason for recall
Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.
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-1297-2024. 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.