Recall Z-2955-2020— Integra LifeSciences Corp.
Class II · Terminated
Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2020-08-04, terminated 2021-08-12. FDA's recall record names no specific 510(k) clearance for this event. Product: Integra Padgett Electric 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.. Reason: lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization..
- Recalling firm
- Integra LifeSciences Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-08-04
- Terminated
- 2021-08-12
- Firm location
- Princeton, NJ, United States
Product description
Integra Padgett Electric 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.
Reason for recall
lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
Data sourced from openFDA. This site is unofficial and independent of the FDA.