Recall Z-2110-2017 ยท FZW Expander, Surgical, Skin Graft
Molnlycke Health Care, Inc
Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts'
| Date | May 3, 2017 (initiated Apr 24, 2017) |
| Status | Open, Classified |
| Reason | Sterilization validation failure. |
| Root cause | Process design |
| Action | Consignees were notified by Urgent Safety Notice letter via certified mail on/about 4/24/2017. |
| Quantity | 956 units |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.