ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Final Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery. .
Class I - DangerousWhat Should You Do?
- Check if you have this product: Item reference SD900.106; Unique Instrument ID MC13-OVA-OGO_2
- 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 USA LLC
- Reason for Recall:
- Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Final Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery. .
Product Codes/Lot Numbers:
Item reference SD900.106; Unique Instrument ID MC13-OVA-OGO_2
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0578-2014
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