FDAFDA · Food and drugs·Recall number Z-2110-2017
Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts'
Published May 24, 2017 · Recall initiated: April 24, 2017
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Sterilization validation failure.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Molnlycke Health Care, Inc
- Distributor
- 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: 131600, 131601, 131602, 131603, 131604, 131500, 131501, 131502, 131503, 131504 and 131506.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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