Home / Recalls / Materialise USA LLC / Z-1941-2016

Z-1941-2016 Class II Terminated

Recalled by Materialise USA LLC — Plymouth, MI

Recall Details

Product Type
Devices
Report Date
June 15, 2016
Initiation Date
May 3, 2016
Termination Date
June 28, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1

Product Description

Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.

Reason for Recall

A patient specific case of Signature Personalized Patient Care System Knee Guides included a femur guide which does not match the patient associated with the case. If the issue is not identified prior to surgery, the personalized patient specific guide would provide an improper fit and would not be able to be used.

Distribution Pattern

One consignee, Indiana.

Code Information

Lot #154970

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-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)