DRILL PT GUIDE WIRE 2MM X 60CM — Class II medical device recall Z-2231-2018
Terminated recall by Zimmer Biomet, Inc., reported 2018-06-27, distributed nationwide. The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceedi
| Recall number | Z-2231-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2018-05-16 |
| Classified | 2018-06-15 |
| Reported by FDA | 2018-06-27 |
| Terminated | 2024-04-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, CA, CL, CO, CR, JP, KR, NL, SV, TT |
| Quantity | 34 |
| Reason classes | sterility |
Product
DRILL PT GUIDE WIRE 2MM X 60CM; 469320 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
Reason for recall
The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.
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-2231-2018. 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.