Z-2110-2017 Class II Ongoing

Recalled by Molnlycke Health Care, Inc — Norcross, GA

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.