Materialise USA LLC: Medical Device Recall in 2014 - (Recall #: Z-0577-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Intermediate Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery.

Product Classification:

Class II

Date Initiated: November 8, 2013

Date Posted: January 1, 2014

Recall Number: Z-0577-2014

Event ID: 66935

Reason for Recall:

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

Status: Terminated

Product Quantity: 1

Code Information:

Item reference SD900.106; Unique Instrument ID MC13-OVA-OGO_01

Distribution Pattern:

Distributed in Canada.

Voluntary or Mandated:

Voluntary: Firm initiated