Z-0578-2014Class II

ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide...

Name: Z-0578-2014 ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide...
Creator: Materialise USA LLC
Published: 2013-11-08
License: https://open.fda.gov/license/

Materialise USA, LLC. / initiated 2013-11-08 / Terminated / root cause: labeling and UDI

FDA source

Materialise USA LLC began a recall of 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... on 2013-11-08. FDA classified it as Class II and gives the reason as "Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0578-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-08
Posted: 2013-12-26
Terminated: 2014-01-07
Recalling firm: Materialise USA, LLC.
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 as surgical tools to transfer a pre-operative plan to surgery. .
Reason for recall: Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Customer/ ordering physician was made aware of the issue11/08/2013. Revised accurate case report was immediately provided.
Quantity in commerce: 1
Distribution: Distributed in Canada.
Product codes and lots: Item reference SD900.106; Unique Instrument ID MC13-OVA-OGO_2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0578-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0577-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-01	2013-12-26
Z-0578-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-01	2013-12-26

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)