Zimmer, Inc.: Device Recall
Recall #Z-0419-2026 · 09/26/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0419-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Zimmer, Inc.
- Status
- Ongoing
- Date Initiated
- 09/26/2025
- Location
- Warsaw, IN, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 63 units
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.
Product Description
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
Distribution Pattern
US: OH, GA, WI, NE, IA, IL, CA, NY, MD, NC, PA, AL, TN, MI, WA, FL, TX, KS, NM, AZ, and CANADA, AUSTRALIA, NETHERLANDS
Other Recalls by Zimmer, Inc.
- Class II: Risk 12/02/2025
- Class II: Risk 12/02/2025
- Class II: Risk 12/02/2025
- Class II: Risk 12/02/2025
- Class II: Risk 12/02/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.