Dual Mobility Vivacit-E Bearing — Class II medical device recall Z-0057-2021
Terminated recall by Zimmer Biomet, Inc., reported 2020-10-14, distributed in FL, ID, IL, IN, KY, MA, MD, MI…. The outer package is labeled as a Size C 38 mm, however, the implant inside the package is a Size E 42 mm.
| Recall number | Z-0057-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2020-08-14 |
| Classified | 2020-10-06 |
| Reported by FDA | 2020-10-14 |
| Terminated | 2022-06-09 |
| Distributed | FL, ID, IL, IN, KY, MA, MD, MI, MN, NC, NJ, OH, OR, PA, SC, TX, UT, VA, WI, WV |
| Quantity | 31 |
| Reason classes | labeling |
| Lot numbers | 64755636 |
| Model numbers | 110031009 |
Product
Dual Mobility Vivacit-E Bearing, Model Number 110031009
Reason for recall
The outer package is labeled as a Size C 38 mm, however, the implant inside the package is a Size E 42 mm.
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-0057-2021. 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.