Recall Z-2289-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-2289-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-24

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2018-05-24, terminated 2020-04-07. It names 2 FDA 510(k) clearances: K171054, K113550. 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.. Reason: 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..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-05-24
Terminated: 2020-04-07
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

2 on FDA's record

K171054 — Biomet Knee Joint Replacement ProsthesesBiomet, Inc.·cleared 2017-07-28
K113550 — VANGUARD COMPLETE KNEE SYSTEMBiomet Manufacturing Corp·cleared 2012-02-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.