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Terminated

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. .

FDA Recall Z-0578-2014 · Posted 2013-12-26

Recalling FirmMaterialise USA LLC
Recall StatusTerminated
Date Initiated2013-11-08
Date Terminated2014-01-07
Product Quantity1

Reason for Recall

Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information.

Firm Action

Customer/ ordering physician was made aware of the issue11/08/2013. Revised accurate case report was immediately provided.

Root Cause

Labeling Change Control

Distribution Pattern

Distributed in Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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