CLASS II Device recall · Reported 1 Jan 2014 · FDA Enforcement Report

ProPlan CMF Guide(s) recalled by Materialise USA

Materialise USA is recalling ProPlan CMF Guide(s). The recall was initiated on 8 Nov 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesItem reference SD900.106; Unique Instrument ID MC13-OVA-OGO_2

Quantity recalled1

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0578-2014
FDA event ID: 66935
Recalling firm: Materialise USA, Plymouth, MI
Classification: Class II
Status: Terminated
Recall initiated: 8 Nov 2013
FDA classified: 26 Dec 2013
Reported: 1 Jan 2014
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

8 Nov 2013	Recall initiated by company
26 Dec 2013	Classified by FDA	+48 days
1 Jan 2014	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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. .

Where it was distributed

Distributed in Canada.

Questions about this recall

Is ProPlan CMF Guide(s) recalled?

Yes. Materialise USA recalled ProPlan CMF Guide(s) on 8 Nov 2013. The recall is Class II and its status is Terminated. Recall number Z-0578-2014.

Why was it recalled?

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

Which lots are affected?

Item reference SD900.106; Unique Instrument ID MC13-OVA-OGO_2

Where was it sold?

Distributed in Canada.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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1 Jan 2014Device	CLASS II	ProPlan CMF Guide(s) recalled by Materialise USA	Materialise USA	Other	MI

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