Recall Z-0495-2019— Zimmer Biomet, Inc.

Name: FDA recall Z-0495-2019
Creator: U.S. Food and Drug Administration
Published: 2018-10-22

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2018-10-22, terminated 2019-12-11. It names 2 FDA 510(k) clearances: K113550, K023546. Product: Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126. Reason: Label on the outer carton or the patient labels does not match label on the inner sterile packaging.

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-10-22
Terminated: 2019-12-11
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

2 on FDA's record

K113550 — VANGUARD COMPLETE KNEE SYSTEMBiomet Manufacturing Corp·cleared 2012-02-29
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 Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126

Reason for recall

Label on the outer carton or the patient labels does not match label on the inner sterile packaging

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