Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient Care System.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 42422461: Signature SIG CT/TI(A Guides 04-05 Slidex Distal-MP/Premier Tibial & 42422551 : Signature TKA GDE/MDL SET 03-05 MP/Premier Distal- MP/Premier Tibial 42422461 139540 2016-02-17 42-422551 1 391 51 2016-01-14 42422551 1 38805 2016-02-03 42-422551 140787 2016-03-03
- 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:
- Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient image data was incorrectly processed.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient Care System.
Product Codes/Lot Numbers:
42422461: Signature SIG CT/TI(A Guides 04-05 Slidex Distal-MP/Premier Tibial & 42422551 : Signature TKA GDE/MDL SET 03-05 MP/Premier Distal- MP/Premier Tibial 42422461 139540 2016-02-17 42-422551 1 391 51 2016-01-14 42422551 1 38805 2016-02-03 42-422551 140787 2016-03-03
Distribution:
Distributed in: MI, ID, TX
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0162-2016
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.