Plastic Trial Head Brown — Class II medical device recall Z-2289-2025
Ongoing recall by Waldemar Link GmbH & Co. KG (Mfg Site), reported 2025-08-20, distributed nationwide. Inconsistent size terminology and color coding used on labeling
| Recall number | Z-2289-2025 |
|---|---|
| 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 | 2025-07-15 |
| Classified | 2025-08-11 |
| Reported by FDA | 2025-08-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, BE, CH, CY, DE, DZ, FI, HU, MX, NL, PE, SI, UY |
| Quantity | 17 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 04026575150700 |
| Serial numbers | C126168, C424053 |
| Model numbers | 175-928/15 |
Product
Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.
Reason for recall
Inconsistent size terminology and color coding used on labeling
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-2289-2025. 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.