FDA Device recall Z-0057-2021
Dual Mobility Vivacit-E Bearing, Model Number 110031009
- FDA Device
- Class II
- terminated
- Published 2020-10-14
On 2020-10-14 the FDA classified a Class II recall of Dual Mobility Vivacit-E Bearing, Model Number 110031009 by Zimmer Biomet, citing the outer package is labeled as a Size C 38 mm, however, the implant inside the package is a Size E 42 mm.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0057-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-08-14 |
| Published | 2020-10-14 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Zimmer Biomet |
| Distribution | FL, ID, IL, IN, KY, MA, MD, MI, MN, NC, NJ, OH, OR, PA, SC, TX, UT, VA, WI, WV |
Product
Dual Mobility Vivacit-E Bearing, Model Number 110031009
Reason
The outer package is labeled as a Size C 38 mm, however, the implant inside the package is a Size E 42 mm.
Identifiers
| code_info | Lot Number 64755636 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0057-2021%22
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