Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Left, Product No. LJU822T
Class I - DangerousWhat Should You Do?
- Check if you have this product: 180080 182904 183671 184878
- 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:
- Integra LifeSciences Corp.
- Reason for Recall:
- The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Left, Product No. LJU822T
Product Codes/Lot Numbers:
180080 182904 183671 184878
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1163-2019
Related Recalls
AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catalog Number): (1) ASX15/60 and (2) ASX15/80
Integra LifeSciences
Possibility for the obturator to break (separate).
Potential that the induction seal is not completely sealed to the device tube packaging.
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.