Vanguard Knee System Prosthesis Components Incorrectly Labeled for Size and Side
Biomet is recalling 157 units of Vanguard Knee System prosthesis components incorrectly labeled as different sizes or surgical sides. Surgeons relying on labels could implant the wrong size or side, requiring corrective 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: This is a Class II recall with no reported illnesses or injuries in the source text. However, the labeling error affects surgical prosthesis components, which are high-risk products. Implanting the wrong size or side would cause patient harm requiring corrective surgery. This fits the criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Biomet, Inc. is recalling 157 units of Vanguard Knee System PS Open Box Femoral prosthesis components in five size variants (60mm, 62.5mm, 65mm, 67.5mm, and 70mm). These components have been distributed internationally to Argentina, China, Costa Rica, India, Japan, Mexico, Netherlands, Ecuador, Republic of Korea, Singapore, and Thailand, as well as to six US states: Florida, Indiana, Maryland, Ohio, Pennsylvania, and Wisconsin.
The recalled components are labeled incorrectly—some are marked as a different size than they actually are, and some are labeled for the wrong surgical side (right vs. left). Because surgical teams rely on product labels to select the correct implant, an incorrectly labeled component could result in implanting the wrong size or side, which would require corrective surgery.
Healthcare facilities that may have received these products should check their inventory against the provided lot numbers and UDI codes, segregate any affected units, and contact their supplier or Biomet directly. Patients who are concerned about previously implanted components should consult with their surgical team.
The recalled product
- Product
- (1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint replacement prostheses. Item Number: 183104 (2) Vanguard Knee System PS Open Box Femoral; Right; 62.5 mm Item Number: 183106 (3) Vanguard Knee System PS Open Box Femoral; Right; 65 mm Item Num
- Manufacturer
- Biomet, Inc.
- Hazard
- incorrect-labeling
- size-mismatch
- side-mismatch
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)
- J7215873 (01)00880304270770(17)320428(10)J7215873
- J7220365 (01)00880304270770(17)320504(10)J7220365
Distribution
Distributed in 6 states:
- FL
- IN
- MD
- OH
- PA
- WI
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