Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene — Class II medical device recall Z-0419-2026
Ongoing recall by Zimmer, Inc., reported 2025-11-12, distributed in AL, AZ, CA, FL, GA, IA, IL, KS…. Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E¿ Bearing d
| Recall number | Z-0419-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2025-09-26 |
| Classified | 2025-11-03 |
| Reported by FDA | 2025-11-12 |
| Distributed | AL, AZ, CA, FL, GA, IA, IL, KS, MD, MI, NC, NE, NM, NY, OH, PA, TN, TX, WA, WI |
| Countries outside the US | AU, CA, NL |
| Quantity | 63 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00889024572713 |
| Lot numbers | 67160480 |
| Model numbers | 110031013 |
Product
Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size G, Bearing, Model/Catalog Number: 110031013; semi constrained hip prosthesis
Reason for recall
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.
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-0419-2026. 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.