ProPlan CMF Guide(s) recall
ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Final Single Use Only Rx only. Used…
Why was ProPlan CMF Guide(s) recalled?
Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Item reference SD900.106; Unique Instrument ID MC13-OVA-OGO_2
- Product
- ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Final Single Use Only Rx only. Used…
- Recalling firm
- Materialise USA LLC
- Quantity
- 1
- Distribution
- Distributed in Canada.
- Recall date
- January 1, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)