Recall Z-2183-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-2183-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-11

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2018-05-11, terminated 2019-11-21. It names 2 FDA 510(k) clearances: K171054, K113550. Product: Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures.. Reason: The label master file was errantly set up as a 63/37mm instead of a 63/67mm. There is no 63/37 size offered, and the product is laser marked with the correct size..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-05-11
Terminated: 2019-11-21
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 Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures.

Reason for recall

The label master file was errantly set up as a 63/37mm instead of a 63/67mm. There is no 63/37 size offered, and the product is laser marked with the correct size.

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