Recall Z-0003-2017— Zimmer Biomet, Inc.

Name: FDA recall Z-0003-2017
Creator: U.S. Food and Drug Administration
Published: 2016-08-08

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2016-08-08, terminated 2017-06-05. It names one FDA 510(k) clearance: K093293. 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..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-08-08
Terminated: 2017-06-05
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K093293 — VANGUARD 360 REVISION KNEE SYSTEMBiomet, Inc.·cleared 2010-10-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.