Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Vanguard 360 Revision Knee System Knee prostheses Recalled by Zimmer Biomet, Inc. Due to The drill bit used to drill the hex...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Zimmer Biomet, Inc. directly.
Affected Products
Vanguard 360 Revision Knee System Knee prostheses
Quantity: 454
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 9 states: AL, CA, KY, MN, OR, PA, TX, UT, VA
About Zimmer Biomet, Inc.
Zimmer Biomet, Inc. has 875 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report