(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 Number: 183108 (4) Vanguard Knee System PS Open Box Femoral; Right; 67.5 mm Item Number: 183110 (5) Vanguard Knee System PS Open Box Femoral; Right; 70 mm Item Number: 183112
Class I - DangerousWhat Should You Do?
- Check if you have this product: (1) UDI: (01)00880304270770(17)320408(10)J7209534 Lot Number: J7209534 Expanded Recall: Lot Numbers/UDI: J7197497 (01)00880304270770(17)320504(10)J7197497, J7215873 (01)00880304270770(17)320428(10)J7215873, J7220365 (01)00880304270770(17)320504(10)J7220365, J7220368 (01)00880304270770(17)320504(10)J7220368. (2) Lot Numbers/UDI: J7133633 (01)00880304270787(17)320504(10)J7133633; J7175232 (01)00880304270787(17)320504(10)J7175232. (3) Lot Number/UDI: J7173881 (01)00880304270794(17)320504(10)J7173881; (4) Lot Number/UDI: J7220405 (01)00880304270080(17)320504(10)J7220405. (5) Lot Number /UDI: J7215860 (01)00880304270817(17)320505(10)J7215860.
- 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:
- Biomet, Inc.
- Reason for Recall:
- Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
(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 Number: 183108 (4) Vanguard Knee System PS Open Box Femoral; Right; 67.5 mm Item Number: 183110 (5) Vanguard Knee System PS Open Box Femoral; Right; 70 mm Item Number: 183112
Product Codes/Lot Numbers:
(1) UDI: (01)00880304270770(17)320408(10)J7209534 Lot Number: J7209534 Expanded Recall: Lot Numbers/UDI: J7197497 (01)00880304270770(17)320504(10)J7197497, J7215873 (01)00880304270770(17)320428(10)J7215873, J7220365 (01)00880304270770(17)320504(10)J7220365, J7220368 (01)00880304270770(17)320504(10)J7220368. (2) Lot Numbers/UDI: J7133633 (01)00880304270787(17)320504(10)J7133633; J7175232 (01)00880304270787(17)320504(10)J7175232. (3) Lot Number/UDI: J7173881 (01)00880304270794(17)320504(10)J7173881; (4) Lot Number/UDI: J7220405 (01)00880304270080(17)320504(10)J7220405. (5) Lot Number /UDI: J7215860 (01)00880304270817(17)320505(10)J7215860.
Distribution:
Distributed in: US, FL, IN, MD, OH, PA, WI
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1042-2023
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