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Zimmer Biomet, Inc. recalls Vanguard Complete Knee System; E1 Vanguard PS Tibial Bearing; Model Numbers EP-183664, EP-183642 Product Usage: The p
Recalled July 4, 2018 · FDA recall Z-2289-2018 · Zimmer Biomet
Hazard
Two lots of tibial bearings were commingled. There is a possibility that a 14mm tibial bearing is packaged in a box labeled as 12 mm tibial bearing and vice versa. This may lead to extension of surgery to find another implant. · FDA Class II
Units
48
Sold at
Distributed to accounts in CA, CT, GA, IA, IN, LA, MA, MD, MN, MS, NJ, OH, PA, TN, TX, UT, VA, WI. Foreign distribution to Taiwan, Japan, and the Netherlands.
Description
Two lots of tibial bearings were commingled. There is a possibility that a 14mm tibial bearing is packaged in a box labeled as 12 mm tibial bearing and vice versa. This may lead to extension of surgery to find another implant.
Product
Vanguard Complete Knee System; E1 Vanguard PS Tibial Bearing; Model Numbers EP-183664, EP-183642 Product Usage: The product is intended for use in knee joint replacement arthroplasties.
Manufacturer(s)
Zimmer Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →