Reported Sep 23, 2020 · Terminated
13 ft Handpiece Cable, component of the Dermatome Sets Model S and Model S6 and also as a spare part - Product Usage:…
Integra LifeSciences Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Integra LifeSciences Corp. · 1100 Campus Rd · Princeton, NJ · 08540-6650
Is this the product you have?
- 13 ft Handpiece Cable, component of the Dermatome Sets Model S and Model S6 and
- also as a spare part - Product Usageare 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
- Lot codes and dates
- Catalog Number353971513
- Catalog DescriptionHandpiece Power Cable Model #: N/A Lot/Serial #: PT-3195
- Amount recalled
- 74 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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