FDAHealthSeptember 26, 2025
Zimmer, Inc. — 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
⚠️ 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.
Is this relevant to me?
- Geography
- US, OH, GA, WI, NE, IA, IL, CA, NY, MD, NC, PA, AL, TN, MI, WA, FL, TX, KS, NM, AZ
- Source agency
- FDA
- Category
- Health
- Published
- September 26, 2025
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
What's affected?
- 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
- Brand
- Zimmer, Inc.
- Lot code
- 67160480
Additional details
UDI (01)00889024572713(17)300406(10)67160480; Lot Number 67160480
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 63 units.
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