Home / Recalls / Materialise USA LLC / Z-0578-2014

Z-0578-2014 Class II Terminated

Recalled by Materialise USA LLC — Plymouth, MI

Recall Details

Product Type
Devices
Report Date
January 1, 2014
Initiation Date
November 8, 2013
Termination Date
January 7, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1

Product Description

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.

Distribution Pattern

Distributed in Canada.

Code Information

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

Other recalls by Materialise USA LLC

  • Z-1569-2022 Class II — ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD90 (July 13, 2022)
  • Z-1941-2016 Class II — Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrumen (May 3, 2016)
  • Z-0418-2015 Class II — Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is in (October 16, 2014)
  • Z-0628-2014 Class II — REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PK (November 26, 2013)
  • Z-0577-2014 Class II — ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Pat (November 8, 2013)