Home / Recalls / Materialise USA LLC / Z-0577-2014

Z-0577-2014 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, Intermediate 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_01

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-0578-2014 Class II — ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Pat (November 8, 2013)