Smooth Guide Wire Bullet Tip 3 — Class II medical device recall Z-1473-2018
Terminated recall by Zimmer Biomet, Inc., reported 2018-05-02, distributed nationwide. Potential failure of sterile packaging seal.
| Recall number | Z-1473-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2018-03-26 |
| Classified | 2018-04-20 |
| Reported by FDA | 2018-05-02 |
| Terminated | 2020-11-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CA, CL, JP, MY, NL, SG, TT |
| Quantity | 19,483 products |
| Reason classes | sterility, packaging |
| Lot numbers | 63619923, 63625354, 63625355, 63625356, 63631736, 63631737, 63638178, 63638179, 63638180, 63638181, 63639395, 63639396, 63639397, 63639398, 63639399, 63639401, 63645656, 63645657, 63645658, 63645659, 63648799, 63648801, 63648802, 63648803, 63650117, 63650118, 63651633, 63651634, 63651635, 63656843, 63662543, 63662544, 63662545, 63662546, 63662547, 63668702, 63668703, 63668721, 63675676, 63675677 and 41 more |
| Model numbers | 47-2255-008-01 |
Product
Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length; Item Number: 47-2255-008-01
Reason for recall
Potential failure of sterile packaging seal.
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-1473-2018. 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.