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Zimmer Biomet, Inc. recalls Vanguard 360 Revision Knee System Knee prostheses

Recalled October 12, 2016 · FDA recall Z-0003-2017 · Zimmer Biomet

Hazard
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. · FDA Class II
Units
454
Sold at
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.

Description

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.

Product
Vanguard 360 Revision Knee System Knee prostheses
Manufacturer(s)
Zimmer Biomet, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →

Zimmer Biomet, Inc. recalls Vanguard 360 Revision Knee System Knee prostheses | RecallWatchUSA