Zimmer Biomet Recalls Vanguard 360 Knee Prostheses Due to Bolt Defect
Zimmer Biomet is recalling 454 Vanguard 360 Revision Knee System prostheses because a manufacturing defect in the tibial augment bolts may prevent them from being fully tightened during surgery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (intraoperative delay and increased anesthesia time) for a medical device where no injuries or illnesses have been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 454 units of the Vanguard 360 Revision Knee System knee prostheses. The recall involves specific Tibial Augment Bolts where the drill bit used to create the hex pre-drilled hole was larger than the allowable process specification. This manufacturing error results in radial cuts into the hex flat, making the hex geometry visible but compromised.
The defect may cause the screwdriver to fail to catch the hex geometry or strip the remaining geometry when the bolt is inserted into the augment. Consequently, the bolt may be unable to be fully tightened. The source text notes that this issue would likely be noticed by the surgeon intraoperatively when they are unable to screw the augment bolts into the augment. This event can result in an intraoperative delay and increased time under anesthesia for the patient.
The affected products were distributed worldwide, including to the US states of VA, UT, TX, OR, MN, AL, PA, CA, and KY, and to the countries of Australia, China, Italy, Netherlands, and Japan. Healthcare providers should check their inventory for the specific lot numbers listed in the recall notice and contact Zimmer Biomet for instructions on how to handle the affected units.
The recalled product
- Product
- Vanguard 360 Revision Knee System Knee prostheses
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 454
Distribution
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