Altrus Thermal Tissue Fusion Handpieces (2013-11-01)

Starting date:

November 1, 2013

Posting date:

December 4, 2013

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-36985

• 
  Reason
• 
  Affected products

Recalled products

A. Altrus Thermal Tissue Fusion Handpieces

Reason

Conmed Corporation confirmed that two lots of Altrus Thermal Tissue Fusion handpiece devices were exposed to a higher than acceptable level of particulate matter during manufacture in March 2013. Device sterility and performance are unaffected by this exposure. These lots were released for distribution without following the specific documentation requirements of Conmed electrosurgery to place the affected products on non-conformance report prior to disposition. In October 2013, conmed notified the USFDA of their intent to recall Altrus Thermal Tissue Fusion handpieces catalog no. 60-9520-001, lot 13CHB007, and 60-9522-001, lot 13CHB006, due to exposure to high particle count during manufacture. Only catalog no. 60-9522-001, lot 13CHB006, was distributed in Canada.

Affected products