Biomet Vanguard XP Knee System Recall for Sizing Defect
Biomet is recalling Vanguard XP Knee System porous femoral components because the AP dimension may be oversized, potentially causing loosening and revision 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 involves a medical device defect that may cause component loosening and require revision surgery, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Biomet, Inc. is recalling 890 units of the Vanguard XP Knee System Porous Femoral Component. The recall covers various sizes and orientations of the total knee replacement system, which is a semi-constrained, uncemented, porous, coated prosthesis made of polymer, metal, and polymer.
The recall is due to a manufacturing defect where the anterior/posterior (AP) dimension of the femoral component may be oversized by 0.016 inches. If the component does not fit as tightly as intended, bony ingrowth may not occur, which can cause the femoral component to loosen. This condition may necessitate a revision surgery.
The affected units were distributed to Utah and the Netherlands. Patients who have had this specific knee component implanted should contact their orthopedic surgeon to discuss the potential risks and the need for monitoring or revision surgery.
The recalled product
- Product
- Vanguard XP Knee System Porous Femoral Component various sizes and orientation a total knee replacement system. prosthesis, knee, patella/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
- Manufacturer
- Biomet, Inc.
- Affected units
- 890
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 (2)
- Part number
- Description
Distribution
Distribution scope not specified by the agency.
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