Medical device recalls Moderate risk

Molnlycke Health Care, Inc recalls Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts'

Recall date
April 24, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2110-2017
FDA classification
Class II
Brand / firm
Molnlycke Health Care, Inc
Sold / distributed
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,…

Why it was recalled

Sterilization validation failure.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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