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Health product recall

ARTHROWAND, TOPAZ MICRODEBRIDER W/INTEGRATED CABLE W/O SUCTION (2016-03-04)

Starting date:
March 4, 2016
Posting date:
May 16, 2016
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-58368

Affected products 

  1. ARTHROWAND, TOPAZ MICRODEBRIDER W/INTEGRATED CABLE W/O SUCTION

Reason

During functional testing, it was determined that product failed to meet shelf-life at the expiration date indicated on the product labels. This action is due to product misbranding. The expiration date is not supported by the real time aging collected. There are no associated immediate or long range health consequences anticipated from the use of or exposure to the defective device.

Affected products

  1. ARTHROWAND, TOPAZ MICRODEBRIDER W/INTEGRATED CABLE W/O SUCTION

Lot or serial number
  • 1032755
Model or catalog number
  • AC4040-01
Companies
Manufacturer
Arthrocare Corporation,
7000 W. William Cannon Drive,
Austin
78735
Texas
UNITED STATES