Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Number: 0469247 Exp. 2021-01-31
- 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:
- Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)
Product Codes/Lot Numbers:
Serial Number: 0469247 Exp. 2021-01-31
Distribution:
Distributed in: NV
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2849-2020
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