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Recall Observatory FDA recall evidence

Device 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

Z-0419-2026

September 26, 2025

Class II

Product summary

Firm
Zimmer, Inc.
Event
Event 97765
Status
Ongoing
Classification
Class II
Quantity
63 units
Official record key
device-enforcement:Z-0419-2026

Official wording

Reason: 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.

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.