Vanguard 360 Revision Knee System Knee prostheses

Class I - Dangerous

🏥 Medical Devices Recalled: August 8, 2016 Zimmer Biomet Implants & Prosthetics

What Should You Do?

Check if you have this product:
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
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Zimmer Biomet, Inc.
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.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

Vanguard 360 Revision Knee System Knee prostheses

Product Codes/Lot Numbers:

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

Distribution:

Distributed in: US, VA, UT, TX, OR, MN, AL, PA, CA, KY

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0003-2017

Related Recalls

Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin cutter - Product Usage: The intended use of this instrument is to be used for cutting orthopedic rods/pins during orthopedic surgeries.

Zimmer Biomet

Class I - Dangerous

Device has the potential for fracture during use.

Nov 20, 2020 Surgical Instruments Nationwide View Details →

Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw system

Zimmer Biomet

Class I - Dangerous

Zimmer Biomet is conducting a medical device correction to update the Instructions for Use (IFU) and the Surgical Techniques for the Polaris Spinal System Translation Screw and Cypher MIS Screw System. Users should be aware that changes were made to the contraindications section indicating that the Translation Screws should not be used with a direct current stimulation, as a high probability of construct failure exists when using Translation Screws containing CoCr with direct current simulation system.

Nov 17, 2020 Other Medical Devices Nationwide View Details →

ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 55 mm Item Number: 00-8065-552-32

Zimmer Biomet

Class I - Dangerous

Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.

Sep 24, 2020 Other Medical Devices Nationwide View Details →