Modular Stem cylindrical — Class II medical device recall Z-1374-2025
Ongoing recall by Waldemar Link GmbH & Co. KG (Mfg Site), reported 2025-03-26, distributed nationwide. A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on
| Recall number | Z-1374-2025 |
|---|---|
| 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 | 2025-02-14 |
| Classified | 2025-03-17 |
| Reported by FDA | 2025-03-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | CH, DE, ES, IT |
| Quantity | 20 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 04026575443949 |
| Lot numbers | 1943277, 1943280 |
Product
Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13
Reason for recall
A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product.
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-1374-2025. 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.