Home / Recalls / Materialise USA LLC / Z-1569-2022

Z-1569-2022 Class II

Recalled by Materialise USA LLC — Plymouth, MI

Recall Details

Product Type
Devices
Report Date
August 31, 2022
Initiation Date
July 13, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 unit

Product Description

ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208

Reason for Recall

MU22-INA-DUQ case was labeled as MU22-INA-DUQ but was shipped with the Anatomical Model of case MU22-NOF-SAK

Distribution Pattern

US Nationwide distribution in the state of MD.

Code Information

Unique Device Identifier (01)05420060352089(10)MU22INADUQ Lot Number: MU22-INQ-DUQ

Other recalls by Materialise USA LLC

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