Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific Surgical Guides are intended to be used as part of the Signature Personalized Patient Care System. Lt is intended to be used as a guide during the surgical procedure for total and partial knee arthroplasty.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot# 124471
- 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:
- Materialise N.V.
- Reason for Recall:
- Images belonging to a different patient were used for the production of the patient specific surgical guide. The incorrect guide may cause a delay in surgery to accommodate the preparation and use of traditional instrumentation.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific Surgical Guides are intended to be used as part of the Signature Personalized Patient Care System. Lt is intended to be used as a guide during the surgical procedure for total and partial knee arthroplasty.
Product Codes/Lot Numbers:
Lot# 124471
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1287-2015
Related Recalls
Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request
The wrong tibia guide was included intended for a different patient case.
The procedure side indicated in the top header of the Shoulder Case Planning Report incorrectly indicated the procedure side as "Left" for surgical plans for a "right" procedure side.