FDA Device recall Z-0003-2017
Vanguard 360 Revision Knee System Knee prostheses
- FDA Device
- Class II
- terminated
- Published 2016-10-12
On 2016-10-12 the FDA classified a Class II recall of Vanguard 360 Revision Knee System Knee prostheses by Zimmer Biomet, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0003-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-08-08 |
| Published | 2016-10-12 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | AL, CA, KY, MN, OR, PA, TX, UT, VA |
Product
Vanguard 360 Revision Knee System Knee prostheses
Reason
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.
Identifiers
| code_info | ITEM LOT DESCRIPTION 185220 262690 BMT 360 TIB AUG 59X5MM 185221 475560 BMT 360 TIB AUG 63X5MM 185222 262720 BMT 360…ITEM LOT DESCRIPTION 185220 262690 BMT 360 TIB AUG 59X5MM 185221 475560 BMT 360 TIB AUG 63X5MM 185222 262720 BMT 360 TIB AUG 67X5MM 185222 475570 BMT 360 TIB AUG 67X5MM 185222 524160 BMT 360 TIB AUG 67X5MM 185222 690770 BMT 360 TIB AUG 67X5MM 185223 421690 BMT 360 TIB AUG 71X5MM 185223 475580 BMT 360 TIB AUG 71X5MM 185223 475590 BMT 360 TIB AUG 71X5MM 185223 524170 BMT 360 TIB AUG 71X5MM 185224 475600 BMT 360 TIB AUG 75X5MM 185224 475610 BMT 360 TIB AUG 75X5MM 185224 524180 BMT 360 TIB AUG 75X5MM 185224 647840 BMT 360 TIB AUG 75X5MM 185224 690790 BMT 360 TIB AUG 75X5MM 185225 342740 BMT 360 TIB AUG 79X5MM 185225 421700 BMT 360 TIB AUG 79X5MM 185225 524190 BMT 360 TIB AUG 79X5MM 185225 524200 BMT 360 TIB AUG 79X5MM 185225 690800 BMT 360 TIB AUG 79X5MM 185226 647850 BMT 360 TIB AUG 83X5MM 185226 751570 BMT 360 TIB AUG 83X5MM 185228 647910 BMT 360 TIB AUG 91X5MM 185228 751420 BMT 360 TIB AUG 91X5MM 185230 524210 BMT 360 TIB AUG 59X10MM 185231 421730 BMT 360 TIB A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0003-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.