Z-0419-2026 Class II Ongoing

Recalled by Zimmer, Inc. — Warsaw, IN

Recall Details

Product Type
Devices
Report Date
November 12, 2025
Initiation Date
September 26, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
63 units

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

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.

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

Code Information

UDI (01)00889024572713(17)300406(10)67160480; Lot Number 67160480