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Health product recall

EVOLUTION MP Total Knee Sys - Tibial Base Keeled (2015-01-28)

Starting date:
January 28, 2015
Posting date:
March 6, 2015
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-43809

Recalled products

  1. Evolution Tibial Base

Reason

Device in question has varying wall thickness and keel offset greater than the maximum allowable tolerance due to a casting issue

Affected products

A. Evolution Tibial Base

Lot or serial number
  • 1560140
Model or catalog number
  • ETPKN8SR
Companies
Manufacturer
Microport Orthopedics Ltd.
5677 Airline Road
Arlington
38002
Texas
UNITED STATES