FDA Device recall Z-0418-2026
Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Catalog Number: 11003…
- FDA Device
- Class II
- ongoing
- Published 2025-11-12
On 2025-11-12 the FDA classified a Class II recall of Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Catalog Number: 11003… by Zimmer, citing zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E¿ Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, ho….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0418-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-26 |
| Published | 2025-11-12 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Zimmer |
| Distribution | AL, AZ, CA, FL, GA, IA, IL, KS, MD, MI, NC, NE, NM, NY, OH, PA, TN, TX, WA, WI |
Product
Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Catalog Number: 110031012; semi constrained hip prosthesis
Reason
Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E¿ Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.
Identifiers
| code_info | UDI (01)00889024572706(17)300406(10)67160447; Lot Number 67160447 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0418-2026%22
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