Zimmer Air Dermatome II Handpiece and Width Plates (2016-07-11)

Starting date:

July 11, 2016

Posting date:

July 22, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

Healthcare Professionals, General Public, Hospitals

Identification number:

RA-59500

• 
  Reason
• 
  Affected products

Affected products

1. ZIMMER AIR DERMATOME II HANDPIECE
2. ZIMMER AIR DERMATOME II WIDTH PLATES

Reason

Zimmer is initiating a device correction (followed by a phased removal) for all serial numbers of the Zimmer Air Dermatome II Handpieces and all lot numbers of the Zimmer Air Dermatome II width plates distributed between July 2012 and March 2014 (including loaner devices). This follows reports that the surface coating applied to the device is blistering, peeling and discolouring after usage over time. Do not return product at this time as part of this action.

Affected products