Zimmer Biomet, Inc. recalls Vanguard Complete Knee System; E1 Vanguard PS Tibial Bearing; Model Numbers EP-183664, EP-183642 Product Usage: The pro…

Recall date

May 24, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2289-2018

FDA classification

Class II

Brand / firm

Zimmer Biomet, Inc.

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.