FDA-Device2017-05-24Class II

Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts'

Molnlycke Health Care, Inc
Hazard

Sterilization validation failure.

Sold states
Domestic: U.S. Nationwide; Foreign: Austria, Australia, Bangladesh, Canada, Chile, Germany, Denmark, Finland, France, Great Britain, Hong Kong, Hungary, Ireland, India, Italy, Jordan, Korea, Kuwait, Malaysia, Norway, New Zealand, Peru, Saudi Arabia, Sweden Switzerland, Taiwan, Turkey, South Africa, United Arab Emirates.
Affected count
956 units
Manufactured in
5550 Peachtree Pkwy Ste 500, Norcross, GA, United States
Products
Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts'

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2110-2017

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