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 hospitals and similar medical facilities, where the patient will be under the supervision of trained personnel.
Reported: September 23, 2020 Initiated: August 4, 2020 #Z-2953-2020
Product Description
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 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.
Details
- Recalling Firm
- Integra LifeSciences Corp.
- Units Affected
- 74 units
- Distribution
- 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).
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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 hospitals and similar medical facilities, where the patient will be under the supervision of trained personnel.. Recalled by Integra LifeSciences Corp.. Units affected: 74 units.
Why was this product recalled? ▼
lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 23, 2020. Severity: Moderate. Recall number: Z-2953-2020.
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