Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures.
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI: (01)00880304673885(17)230222(10)120150, Lot Number: 120150; UDI: (01)00880304673885(17)201203(10)140700, Lot Number: 140700; UDI: (01)00880304673885(17)211125(10)173480, Lot Number: 173480; UDI: (01)00880304673885(17)210520(10)205730, Lot Number: 205730; UDI: (01)00880304673885(17)210822(10)294370, Lot Number: 294370; UDI: (01)00880304673885(17)210310(10)338750, Lot Number: 338750; UDI: (01)00880304673885(17)210902(10)421970, Lot Number: 421970; UDI: (01)00880304673885(17)210916(10)516680, Lot Number: 516680; UDI: (01)00880304673885(17)210411(10)678370, Lot Number: 678370; UDI: (01)00880304673885(17)220603(10)700470, Lot Number: 700470; UDI: (01)00880304673885(17)201015(10)722060, Lot Number: 722060; UDI: (01)00880304673885(17)230130(10)775330, Lot Number: 775330; UDI: (01)00880304673885(17)220620(10)858220, Lot Number: 858220; UDI: (01)00880304673885(17)211101(10)888080, Lot Number: 888080; UDI: (01)00880304673885(17)220221(10)992290, Lot Number: 992290
- 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:
- Zimmer Biomet, Inc.
- Reason for Recall:
- The label master file was errantly set up as a 63/37mm instead of a 63/67mm. There is no 63/37 size offered, and the product is laser marked with the correct size.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures.
Product Codes/Lot Numbers:
UDI: (01)00880304673885(17)230222(10)120150, Lot Number: 120150; UDI: (01)00880304673885(17)201203(10)140700, Lot Number: 140700; UDI: (01)00880304673885(17)211125(10)173480, Lot Number: 173480; UDI: (01)00880304673885(17)210520(10)205730, Lot Number: 205730; UDI: (01)00880304673885(17)210822(10)294370, Lot Number: 294370; UDI: (01)00880304673885(17)210310(10)338750, Lot Number: 338750; UDI: (01)00880304673885(17)210902(10)421970, Lot Number: 421970; UDI: (01)00880304673885(17)210916(10)516680, Lot Number: 516680; UDI: (01)00880304673885(17)210411(10)678370, Lot Number: 678370; UDI: (01)00880304673885(17)220603(10)700470, Lot Number: 700470; UDI: (01)00880304673885(17)201015(10)722060, Lot Number: 722060; UDI: (01)00880304673885(17)230130(10)775330, Lot Number: 775330; UDI: (01)00880304673885(17)220620(10)858220, Lot Number: 858220; UDI: (01)00880304673885(17)211101(10)888080, Lot Number: 888080; UDI: (01)00880304673885(17)220221(10)992290, Lot Number: 992290
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2183-2018
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