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: 110031
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Zimmer, Inc.
- 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 / hazard
- 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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
- Recall initiated
- 2025-09-26
- Code info
- UDI (01)00889024572713(17)300406(10)67160480; Lot Number 67160480
- Product quantity
- 63 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Warsaw
- State
- IN
- Country
- United States
- Event id
- 97765
Free daily digest + "My products" watchlist