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.
FDA Recall Z-2953-2020 · Posted 2020-09-12
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Recalling FirmIntegra LifeSciences Corp.
Recall StatusTerminated
Product CodeGFD
Date Initiated2020-08-04
Date Terminated2021-08-12
Product Quantity74 units
Reason for Recall
lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
Firm Action
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.
Root Cause
Mixed-up of materials/components
Distribution Pattern
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).
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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