Tibial Alignment Guide; Orthopedic Stereotaxic Instrument;
Class I - DangerousWhat Should You Do?
- Check if you have this product: Item Number: 20-8011-013-00; Lot Numbers: 120265; 110623; 120659; 120794;120659-1; 130134; 120793; 130135
- 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 CAS
- Reason for Recall:
- Zimmer CAS has determined that the potential exists for the spikes on the iASSIST Tibial Alignment Guide to bend or break during insertion or extraction from the tibia during use.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Tibial Alignment Guide; Orthopedic Stereotaxic Instrument;
Product Codes/Lot Numbers:
Item Number: 20-8011-013-00; Lot Numbers: 120265; 110623; 120659; 120794;120659-1; 130134; 120793; 130135
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1701-2015
Related Recalls
Class I - Dangerous
Internal discovery found that the MRI scans in some PSI knee guides involved an additional rotation adjustments that could potentially lead to misalignment due to a design flaw.