ConForMIS iUni Unicondylar Knee Replacement System- iUNI G2, Right Medial Catalog Number:M57220600220 (US) M5722INT0600220 (OUS)
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Numbers (US): 0355146 0354541 0355265 0354782 0355485 0355303 0352821 0354413 0353756 0351007 0354577 0354250 0352676 0354571 0353838 0353285 0347734 0354520 0354841 0354148 0353307 0355478 0354830 0353427 0353729 0353683 0353887 0351415 0354255 0354219 0355807 0353995 0352944 0353305 0352331 Serial Numbers (OUS): 0347979 0349420 0351218 0351279 0351682 0351688 0351754 0351856 0352523 0352868 0352918 0353077 0353416 0353745 0353805 0353933 0354141 0354189 0354190 0354267 0354325 0354421 0354427 0354561 0354600 0354646 0354678 0354810 0354850 0355339 0355382 0355385
- 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:
- ConforMIS, Inc.
- Reason for Recall:
- May contain small amounts of ethylene glycol residue
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
ConForMIS iUni Unicondylar Knee Replacement System- iUNI G2, Right Medial Catalog Number:M57220600220 (US) M5722INT0600220 (OUS)
Product Codes/Lot Numbers:
Serial Numbers (US): 0355146 0354541 0355265 0354782 0355485 0355303 0352821 0354413 0353756 0351007 0354577 0354250 0352676 0354571 0353838 0353285 0347734 0354520 0354841 0354148 0353307 0355478 0354830 0353427 0353729 0353683 0353887 0351415 0354255 0354219 0355807 0353995 0352944 0353305 0352331 Serial Numbers (OUS): 0347979 0349420 0351218 0351279 0351682 0351688 0351754 0351856 0352523 0352868 0352918 0353077 0353416 0353745 0353805 0353933 0354141 0354189 0354190 0354267 0354325 0354421 0354427 0354561 0354600 0354646 0354678 0354810 0354850 0355339 0355382 0355385
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0141-2016
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30mm screws were labeled as 25mm screws.