Reported Jan 1, 2014 · Terminated
ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Final…
Materialise USA LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Materialise USA LLC · 44650 Helm Ct · Plymouth, MI · 48170-6061
Is this the product you have?
- ProPlan CMF Guide(s) Model(s) REF SD900.008
- DescriptionSingle
- Use OnlyPatient-Specific Guide, Orthognathic, Final Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery
- Lot codes and dates
Item reference SD900.106Unique Instrument ID MC13-OVA-OGO_2
- Amount recalled
- 1
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information.
This product could cause temporary or reversible health problems — stop using it.
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