Vanguard 360 Revision Knee System Knee prostheses — Class II medical device recall Z-0003-2017
Terminated recall by Zimmer Biomet, Inc., reported 2016-10-12, distributed in AL, CA, KY, MN, OR, PA, TX, UT…. The drill bit used to drill the hex pre-drilled hole in the screw head of the Tibial Augment Bolts included in
| Recall number | Z-0003-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2016-08-08 |
| Classified | 2016-10-03 |
| Reported by FDA | 2016-10-12 |
| Terminated | 2017-06-05 |
| Distributed | AL, CA, KY, MN, OR, PA, TX, UT, VA |
| Countries outside the US | AU, CN, IT, JP, NL |
| Quantity | 454 |
Product
Vanguard 360 Revision Knee System Knee prostheses
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.