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Zimmer dermatome blades

Official notice

21 Sept 2023

Last checked

21 Sept 2023

Medium riskHealth Canada

An official Health Canada notice concerns Zimmer dermatome blades. 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 Published 2023-09-21.

What to do now

Contact the manufacturer if you require additional information.

Recall number

74309

Official notice

2023-09-21

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Lots

specific

Recall Numbers

74309

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Affected products

Product 1

Affected products - Zimmer Dermatome Blades, Lot or serial number - 65630969 65925347 65935738 65709066 65988623 65972711 65599469 65648460 65952858 65952857, Model or catalogue number - 00-8800-000-10

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Zimmer Surgical, Zimmer Dermatome Blades.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

74309

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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