Recall Z-3249-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-3249-2018
Creator: U.S. Food and Drug Administration
Published: 2018-08-02

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2018-08-02, terminated 2019-04-25. It names one FDA 510(k) clearance: K093293. Product: Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, Model Number 185221 Intended for use in Total Knee Arthroplasty. Reason: The implant only has one bolt in the sterile package but it should have had two..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-08-02
Terminated: 2019-04-25
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 Knee System 63x 10mm Universal Tibial Block Augment, Model Number 185221 Intended for use in Total Knee Arthroplasty

Reason for recall

The implant only has one bolt in the sterile package but it should have had two.

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