Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts'
This recall is currently active, issued May 3, 2017. It was issued by Molnlycke Health Care, Inc.
- Company
- Molnlycke Health Care, Inc
- Recall Initiated
- April 24, 2017
- Posted
- May 3, 2017
- Recall Number
- Z-2110-2017
- Quantity
- 956 units
- Firm Location
- Norcross, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Sterilization validation failure.
Distribution
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.
Lot / Code Info
Code: 131600, 131601, 131602, 131603, 131604, 131500, 131501, 131502, 131503, 131504 and 131506.
Root Cause
Process design
Action Taken
Consignees were notified by Urgent Safety Notice letter via certified mail on/about 4/24/2017.
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