FDA-Device2023-10-11Class II
Zimmer Dermatome Blades- 10-pack boxes of blades. Intended for use with the dermatome handpiece which is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities Part number: 00880000010
Zimmer Surgical Inc
Hazard
Skin grafts 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
Sold states
US Nationwide Foreign: AUSTRALIA BRAZIL CHINA HONG KONG INDIA JAPAN MALAYSIA MEXICO NETHERLANDS ON SEOUL SINGAPORE TAIWAN THAILAND
Affected count
11,985 boxes (119,850 blades)
Manufactured in
200 W Ohio Ave, N/A, Dover, OH, United States
Products
Zimmer Dermatome Blades- 10-pack boxes of blades. Intended for use with the dermatome handpiece which is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities Part number: 00880000010
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0069-2024Don't want to check this manually?
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