Integra LifeSciences Recalls 13 ft Handpiece Cables for Dermatome Sets
Integra LifeSciences is recalling 74 units of 13 ft handpiece cables used in dermatome sets because the cables melt after sterilization.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a medical device component melting during sterilization, which poses a risk of harm in a clinical setting without reported injuries.
Plain-English summary
Integra LifeSciences Corp. is recalling 74 units of 13 ft handpiece cables, which are components of the Dermatome Sets Model S and Model S6 and also sold as spare parts. These cables are intended for use in cutting skin grafts for plastic surgery and burn treatment in professional medical facilities. The recall was initiated after the company received multiple complaints indicating that the handpiece cables melt following sterilization.
The affected products have a catalog number of 353971513 and a lot/serial number of PT-3195. The distribution was worldwide, including nationwide distribution in the United States across states such as Minnesota, Texas, California, Utah, West Virginia, Florida, Indiana, Georgia, and Arizona, as well as in Latin America, Canada, and Europe.
Healthcare facilities and users of these instruments should stop using the affected handpiece cables immediately. The recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- 13 ft Handpiece Cable, component of the Dermatome Sets Model S and Model S6 and also as a spare part - 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 h
- Manufacturer
- Integra LifeSciences Corp.
- Affected units
- 74
Distribution
Part of a larger recall action
This product is one of 3 recalled by Integra LifeSciences Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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