medical Class II Updated 2018-07-04

Zimmer Biomet, Inc. recalls Vanguard Complete Knee System; E1 Vanguard PS Tibial Bearing

Recalled 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.

Hazard / Issue

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.

Issued by

FDA

Affected States: CA, CT, GA, IA, IN, LA, MA, MD, MN, MS, NJ, OH, PA, TN, TX, UT, VA, WI
Lot/Code Info: Lots 198810 and 210320
View official government recall

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