Medical Device Recall: 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, Inc. · September 26, 2025
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
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
States Affected
AL, AZ, CA, FL, GA, IA, IL, KS, MD, MI, NC, NE, NM, NY, OH, PA, TN, TX, WA, WI
Quantity Affected
63 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0419-2026
Status: ongoing
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