Home / Recalls / Materialise USA LLC / Z-0418-2015

Z-0418-2015 Class II Terminated

Recalled by Materialise USA LLC — Plymouth, MI

Recall Details

Product Type
Devices
Report Date
December 3, 2014
Initiation Date
October 16, 2014
Termination Date
February 17, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1

Product Description

Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

Reason for Recall

The box of guides for a specific case arrived intact but contained two (2) femoral guides instead of one (1) femoral guide and one (1) tibial guide. The device did not meet specification: One tibia guide missing and one femur guide contained an edge which was +0.04 mm over specification.

Distribution Pattern

Nationwide Distribution to MN only

Code Information

00-5970-000-25 JTOMA-JL-0636-L8 Pin Guide LOT#: 56602902

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-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)