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CLASS II · ModerateFDA

Zimmer, Inc. recalls Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene

📅 Sep 26, 2025 · 📍 AL, AZ, CA, FL, GA, IA, IL, KS +12
Recalling company
Zimmer, Inc.
Product
Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Catalog Number: 110031012; semi constrained hip prosthesis
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.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Sep 26, 2025
Reported
Nov 12, 2025
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
Status
Ongoing
Quantity
72 units
Lot / codes
UDI (01)00889024572706(17)300406(10)67160447; Lot Number 67160447
Company location
Warsaw, IN
Recall type
Voluntary: Firm initiated
Recall number
Z-0418-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0418-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.