Home / Recalls / Materialise USA LLC / Z-0628-2014

Z-0628-2014 Class II Terminated

Recalled by Materialise USA LLC — Plymouth, MI

Recall Details

Product Type
Devices
Report Date
January 15, 2014
Initiation Date
November 26, 2013
Termination Date
January 14, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1

Product Description

REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PKA GDE/MDL SET SML-MP DD.....R-FEB55RKA-T JA-A01 05551 PKA POST CUT SML-PKA MICROPLASTY CUSTOM-MADE DEVICE non-sterile The Signature Personalized Patient Care System includes the patient-specific Signature Guides which are patient specific instruments (guides are considered custom-made per EU definition) intended for use during the surgical procedure for total and partial knee arthroplasty.

Reason for Recall

Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert.

Distribution Pattern

US Distribution: MO only.

Code Information

Lot 094929

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-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)