United StatesZimmer Biomet Dual Mobility Vivacit‑E Highly Crosslinked Polyethylene hip bearings (28 mm I.D.) in two configurations — 44 mm O.D., Size F (Model 110031012, Lot 67160447, UDI (01)00889024572706(17)300406(10)67160447) and 46 mm O.D., Size G (Model 110031013, Lot 67160480, UDI (01)00889024572713(17)300406(10)67160480) — are affected. They were recalled because some outer packages are mislabeled: a package labeled Size F 44 mm may contain a Size G 46 mm implant, and vice versa.
What's being recalled
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
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
Recalling firm: Zimmer, Inc., Warsaw, IN, United States.
How to identify it
UDI (01)00889024572706(17)300406(10)67160447; Lot Number 67160447 UDI (01)00889024572713(17)300406(10)67160480; Lot Number 67160480
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)