ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111. Intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Numbers: 0381024; 0381042 Exp Date: 2017-02-28
- 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:
- Mislabeled: incorrect serial number on the F4 A/P cut guide iJig.
- 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, Sterile Catalog Number: TCR-111-1111. Intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device.
Product Codes/Lot Numbers:
Serial Numbers: 0381024; 0381042 Exp Date: 2017-02-28
Distribution:
Distributed in: CO, NV
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0658-2017
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