Zimmer Humeral Guide Wire — Class II medical device recall Z-0536-2019
Terminated recall by Zimmer Biomet, Inc., reported 2018-12-12, distributed nationwide. Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening c
| Recall number | Z-0536-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2018-10-22 |
| Classified | 2018-11-30 |
| Reported by FDA | 2018-12-12 |
| Terminated | 2020-12-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CA, CL, HK, JP, MY, NI, NL, SG, TW |
| Quantity | 8,027 |
| Reason classes | sterility |
| Model numbers | 47-2255-008-00 |
Product
Zimmer Humeral Guide Wire - Ball Tip, 2.4 mm Diameter, 70 cm Length Item Number: 47-2255-008-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Reason for recall
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
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-0536-2019. 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.