FDAFDA · Food and drugs·Recall number Z-0577-2014
ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Intermediate Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery.
Published January 1, 2014 · Recall initiated: November 8, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Materialise USA LLC
- Distributor
- Distributed in Canada.
- Lot
- Item reference SD900.106; Unique Instrument ID MC13-OVA-OGO_01
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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