Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement… — Class II medical device recall Z-2056-2017
Terminated recall by Zimmer Biomet, Inc., reported 2017-05-17, distributed in TX. Six complaints were filed regarding loss of the Zimmer Biomet applied seal of a sterile Tyvek packaging. A bre
| Recall number | Z-2056-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2017-04-13 |
| Classified | 2017-05-09 |
| Reported by FDA | 2017-05-17 |
| Terminated | 2019-03-26 |
| Distributed | TX |
| Countries outside the US | JP, MX |
| Quantity | 4,238 |
| Reason classes | sterility, packaging |
| Lot numbers | 189780, 402282, 402282J, 402283J, 507830, 508220, 668140 |
| Model numbers | 402282, 402282J |
Product
Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentamicin
Reason for recall
Six complaints were filed regarding loss of the Zimmer Biomet applied seal of a sterile Tyvek packaging. A breach in the packaging could lead to loss of sterility of the device.
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-2056-2017. 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.