Vanguard 360 Revision Knee System Knee prostheses

FDA device recall Z-0003-2017 · posted 2016-10-03 · Terminated

Recall details

Recalling firm

Zimmer Biomet, Inc.

Reason for recall

The drill bit used to drill the hex pre-drilled hole in the screw head of the Tibial Augment Bolts included in the Vanguard 360 Revision Knee System was larger than allowable per the process specification. As a result, the hex geometry can still be visible, but there are radial cuts into the hex flat. Therefore, when the bolt is inserted into the augment, the screwdriver is unable to catch on the hex geometry, or the screwdriver strips the remaining hex geometry, and the bolt is unable to be fully tightened. The bolt stripping or the bolt not being fully tightened will be noticed by the surgeon intraoperatively when he or she is unable to screw the augment bolts into the augment. This possible event can result in an intraoperative delay resulting in increased time under anesthesia.

Action taken

Zimmer Biomet sent an URGENT MEDICAL DEVICE RECALL REMOVAL notifications dated August 8, 2016, to all affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If after reviewing this notice you have further questions or concerns please call 1-800-348-9500 ext. 1251 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of business hours will receive a prompt to record a voicemail and will be returned upon receipt. Alternatively, your questions may be sent by email to CPWARFieldAction@zimmerbiomet.com. For further questions, please call (800) 348-2759.

Root cause

Process control

Status

Terminated

Product code

JWH

Quantity affected

454

Distribution

Worldwide Distribution - US Distribution to the states of : VA, UT, TX. OR, MN, AL, PA, CA and KY., and to the countries of : AUSTRALIA, China, Italy, Netherlands and Japan.

Date initiated

2016-08-08

Date posted

2016-10-03

Date terminated

2017-06-05

Location

Warsaw, IN

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