Recall Z-0674-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-0674-2018
Creator: U.S. Food and Drug Administration
Published: 2017-09-29

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-09-29, terminated 2019-04-17. It names one FDA 510(k) clearance: K023546. Product: Vanguard Complete Knee System, Vanguard CR Lipped Tibial Bearing 10x71/75, Item Number: 183540 Product Usage: For use in total knee arthroplasty. Reason: Knee implant components (tibial bearings) are labeled with the incorrect size..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-09-29
Terminated: 2019-04-17
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K023546 — MAXIM ACCEL KNEE SYSTEMBiomet, Inc.·cleared 2003-01-17

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, Vanguard CR Lipped Tibial Bearing 10x71/75, Item Number: 183540 Product Usage: For use in total knee arthroplasty

Reason for recall

Knee implant components (tibial bearings) are labeled with the incorrect size.

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