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Health Canada Medical devices

Zimmer Dermatome Blades

Issued September 21, 2023
Issue
Zimmer Biomet Canada is initiating a lot specific recall for the Zimmer dermatome blades (00-8800-000-10) in Canada. There have been 38 complaints received related to skin grafts being thin and non-uniform when using the affected blades. The issue would be identified at the time of use and may result in the need for additional harvests to adequately cover the area. The trade-off of incomplete coverage versus having additional grafts is at the discretion of the health care provider based on the condition of the graft, overall patient condition, and severity of the need for the graft. The investigation identified an assignable cause within the manufacturing process, which was present for a defined amount Recall start date: September 12, 2023
Hazard description
Performance
Product
Product name
Zimmer Dermatome Blades
Reference
ID
RA-74309