Biomet Vanguard 360 Knee Augment Recall Due to Incorrect Bolts
Biomet is recalling 21 units of Vanguard 360 Revision System Posterior Augments because tibial bolts were packaged instead of femoral bolts, which may delay knee arthroplasty procedures.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a packaging error that may delay a procedure rather than cause direct physical injury or death, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Biomet, Inc. is recalling 21 units of the Vanguard 360 Revision System Posterior Augment With Bolt (Item Number 185422). The recall is due to a packaging error where tibial bolts were included in the package instead of the required femoral bolts. This error may delay knee arthroplasty procedures.
The affected product is identified by Lot Number 098780 and UDI Number (01) 00880304482739 (17) 290501 (10) 098780. The units were distributed worldwide, including in the United States (specifically Florida) and in Korea, Japan, and the Netherlands.
Healthcare providers and facilities should check their inventory for this specific lot number and stop using the affected units. Biomet is the recalling firm responsible for managing this Class II recall.
The recalled product
- Product
- Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in knee arthroplasty Item Number: 185422
- Manufacturer
- Biomet, Inc.
- Affected units
- 21
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: 098780 UDI Number: (01) 00880304482739 (17) 290501 (10) 098780
Distribution
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