Recall Z-0723-2021— Biomet, Inc.

Name: FDA recall Z-0723-2021
Creator: U.S. Food and Drug Administration
Published: 2020-12-01

Class II · Terminated

Class II FDA medical device recall by Biomet, Inc., initiated 2020-12-01, terminated 2022-07-08. It names one FDA 510(k) clearance: K093293. Product: Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in knee arthroplasty Item Number: 185422. Reason: Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure.

Recalling firm: Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-12-01
Terminated: 2022-07-08
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K093293 — VANGUARD 360 REVISION KNEE SYSTEMBiomet, Inc.·cleared 2010-10-22

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 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in knee arthroplasty Item Number: 185422

Reason for recall

Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure

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