Recall Z-0937-2019— Zimmer Biomet, Inc.

Name: FDA recall Z-0937-2019
Creator: U.S. Food and Drug Administration
Published: 2018-12-21

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2018-12-21, terminated 2020-05-13. It names one FDA 510(k) clearance: K040770. Product: Vanguard Knee System Series-A Standard Patella sizes 31mm Item Number: 184764. Reason: Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-12-21
Terminated: 2020-05-13
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K040770 — VANGUARD PATELLA COMPONENTSBiomet Manufacturing, Inc.·cleared 2004-04-22

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 Series-A Standard Patella sizes 31mm Item Number: 184764

Reason for recall

Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label.

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