Integra Padgett Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. These instruments are intended only for professional use in hospitals and similar medical facilities, where the patient will be under the supervision of trained personnel.
Recall
- Recall Number
- Z-2954-2020
- Event Number
- 86240
- Firm
- Integra LifeSciences Corp.
- FEI Number
- 3003418325
- Product Code
- GFD
- Status
- Terminated
- Root Cause
- Mixed-up of materials/components
- Initiated
- August 4, 2020
- Posted
- September 12, 2020
- Terminated
- August 12, 2021
- Address
- 1100 Campus Rd, Princeton, NJ, 08540-6650
Description
Integra Padgett Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. These instruments are intended only for professional use in hospitals and similar medical facilities, where the patient will be under the supervision of trained personnel.
lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
All impacted consignees will be notified by letter delivered by courier service, facsimile or email about the initial notification between August 4th and 6th, 2020. Customers are asked to remove the affected product from use and complete and return the response form to the manufacturer. After response forms are reviewed the customer will be asked to return the product and a replacement will be sent.
Worldwide distribution - US Nationwide distribution including in the states of MN, TX, CA, UT, WV, FL, IN, GA, AZ, and the countries of Latin America ( CR, MX, TT, EC, PA ), Canada, Europe (FR, AT, BE, ES).
13 units