Recall Z-1011-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-1011-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-03

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-10-03, terminated 2018-08-23. It names one FDA 510(k) clearance: K113550. Product: Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty. Reason: The affected products are labeled as a 62.5mm LEFT Femur; however, the contents are a Vanguard 70mm RIGHT Femur..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-10-03
Terminated: 2018-08-23
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

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 CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty

Reason for recall

The affected products are labeled as a 62.5mm LEFT Femur; however, the contents are a Vanguard 70mm RIGHT Femur.

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