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Class 2 Device Recall Vanguard 360 Revision Knee System |
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| Date Initiated by Firm |
August 08, 2016 |
| Date Posted |
October 03, 2016 |
| Recall Status1 |
Terminated 3 on June 05, 2017 |
| Recall Number |
Z-0003-2017 |
| Recall Event ID |
75235 |
| 510(K)Number |
K093293
|
| Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
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| Product |
Vanguard 360 Revision Knee System
Knee prostheses |
| Code Information |
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 AUG 63X10MM 185231 475620 BMT 360 TIB AUG 63X10MM 185231 524220 BMT 360 TIB AUG 63X10MM 185232 377450 BMT 360 TIB AUG 67X10MM 185232 377460 BMT 360 TIB AUG 67X10MM 185232 421750 BMT 360 TIB AUG 67X10MM 185232 475630 BMT 360 TIB AUG 67X10MM 185232 524230 BMT 360 TIB AUG 67X10MM 185233 342750 BMT 360 TIB AUG 71X10MM 185233 377470 BMT 360 TIB AUG 71X10MM 185233 475640 BMT 360 TIB AUG 71X10MM 185233 524240 BMT 360 TIB AUG 71X10MM 185234 262780 BMT 360 TIB AUG 75X10MM 185234 262790 BMT 360 TIB AUG 75X10MM 185234 524250 BMT 360 TIB AUG 75X10MM 185235 421770 BMT 360 TIB AUG 79X10MM 185235 421780 BMT 360 TIB AUG 79X10MM 185237 229750 BMT 360 TIB AUG 87X10MM 185238 229760 BMT 360 TIB AUG 91X10MM 185238 262820 BMT 360 TIB AUG 91X10MM 185239 511390 BMT 360 TIB AUG BOLT 10MM 185241 148190 BMT 360 TIB AUG 63X15MM RL/LM 185242 969710 BMT 360 TIB AUG 67X15MM RL/LM 185243 377480 BMT 360 TIB AUG 71X15MM RL/LM 185247 262750 BMT 360 TIB AUG 87X15 RL/LM 185250 421790 BMT 360 TIB AUG 59X15MM LL/RM 185251 262770 BMT 360 TIB AUG 63X15MM LL/RM 185253 421800 BMT 360 TIB AUG 71X15MM LL/RM 185254 229770 BMT 360 TIB AUG 75X15MM LL/RM 185255 229780 BMT 360 TIB AUG 79X15MM LL/RM 185256 988680 BMT 360 TIB AUG 83X15MM LL/RM 185257 148210 BMT 360 TIB AUG 87X15 LL/RM 185229-00 493640 BMT TIB AUG BOLT 5MM 185229-00 582090 BMT TIB AUG BOLT 5MM 185229-00 582100 BMT TIB AUG BOLT 5MM 185229-00 582110 BMT TIB AUG BOLT 5MM 185229-00 590570 BMT TIB AUG BOLT 5MM 185229-00 789260 BMT TIB AUG BOLT 5MM 185239-00 493690 BMT 360 TIB AUG BOLT 10MM 185239-00 590580 BMT 360 TIB AUG BOLT 10MM 185239-00 590590 BMT 360 TIB AUG BOLT 10MM 185239-00 590600 BMT 360 TIB AUG BOLT 10MM 185239-00 590610 BMT 360 TIB AUG BOLT 10MM 185239-00 590620 BMT 360 TIB AUG BOLT 10MM 185239-00 590630 BMT 360 TIB AUG BOLT 10MM 185239-00 666760 BMT 360 TIB AUG BOLT 10MM 185239-00 666780 BMT 360 TIB AUG BOLT 10MM |
Recalling Firm/
Manufacturer |
Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
|
| For Additional Information Contact |
Customer Service
800-348-2759
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Manufacturer 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.
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FDA Determined
Cause 2 |
Process control |
| Action |
Zimmer Biomet sent an URGENT MEDICAL DEVICE RECALL REMOVAL notifications dated August 8, 2016, to all affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
If after reviewing this notice you have further questions or concerns please call 1-800-348-9500 ext. 1251 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of business hours will receive a prompt to record a voicemail and will be returned upon receipt. Alternatively, your questions may be sent by email to CPWARFieldAction@zimmerbiomet.com. For further questions, please call (800) 348-2759. |
| Quantity in Commerce |
454 |
| Distribution |
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. |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database |
510(K)s with Product Code = JWH and Original Applicant = BIOMET, INC.
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