Z-2110-2017 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 24, 2017
- Initiation Date
- April 24, 2017
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 956 units
Product Description
Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts'
Reason for Recall
Sterilization validation failure.
Distribution Pattern
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.
Code Information
Code: 131600, 131601, 131602, 131603, 131604, 131500, 131501, 131502, 131503, 131504 and 131506.