Pressure Sentinel Intramedullary Reaming System Guide Wire Bullet Tip… — Class II medical device recall Z-1471-2018
Terminated recall by Zimmer Biomet, Inc., reported 2018-05-02, distributed nationwide. Potential failure of sterile packaging seal.
| Recall number | Z-1471-2018 |
|---|---|
| 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 | 63655999, 63715685, 63731170, 63733045, 63812299 |
| Model numbers | 00-2228-024-00 |
Product
Pressure Sentinel Intramedullary Reaming System Guide Wire Bullet Tip 2.4 mm Diameter; Item Number: 00-2228-024-00
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-1471-2018. 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.