ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures. Identification number: SD900.101
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI: 05420060351013 Lot Case Number: MU23-JOQ-LID
- 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:
- Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- completed
Product Information
Full Description:
ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures. Identification number: SD900.101
Product Codes/Lot Numbers:
UDI: 05420060351013 Lot Case Number: MU23-JOQ-LID
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2287-2023
Related Recalls
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.
Custom surgical kits contain a plate different than indicated by the package labeling.