CLASS II Device recall · Reported 23 Sep 2020 · FDA Enforcement Report
13 ft Handpiece Cable, component of the Dermatome Sets recalled
Integra LifeSciences is recalling 13 ft Handpiece Cable, component of the Dermatome Sets, distributed nationwide in the US. The recall was initiated on 4 Aug 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2953-2020
- FDA event ID
- 86240
- Recalling firm
- Integra LifeSciences, Princeton, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Aug 2020
- FDA classified
- 11 Sep 2020
- Reported
- 23 Sep 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 4 Aug 2020 | Recall initiated by company | |
| 11 Sep 2020 | Classified by FDA | +38 days |
| 23 Sep 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
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).
Nationwide ArizonaCaliforniaFloridaGeorgiaIndianaMinnesotaPennsylvaniaTexasUtahWest Virginia
Questions about this recall
Is 13 ft Handpiece Cable, component of the Dermatome Sets recalled?
Yes. Integra LifeSciences recalled 13 ft Handpiece Cable, component of the Dermatome Sets on 4 Aug 2020. The recall is Class II and its status is Terminated. Recall number Z-2953-2020.
Why was it recalled?
lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
Which lots are affected?
Catalog Number: 353971513 Catalog Description: Handpiece Power Cable Model #: N/A Lot/Serial #: PT-3195
Where was it sold?
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).
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Integra LifeSciences
All 246| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Aurora Surgiscope System, Sterile recalled by Integra LifeSciences | Integra LifeSciences | Sterility | Nationwide |
| Device | CLASS II | MediHoney¿ Gel MediHoney¿ Wound & Burn Dressing Gel recalled | Integra LifeSciences | Packaging Defects | Nationwide |
| Device | CLASS II | Codman Certas Plus Programmable Valve Inline Small Valve Only recalled | Integra LifeSciences | Packaging Defects | Nationwide |
| Device | CLASS II | Codman Certas Plus Programmable Valve Right Angle Valve Only recalled | Integra LifeSciences | Packaging Defects | Nationwide |
| Device | CLASS II | Codman Certas Plus Programmable Valve Inline Small Valve Only recalled | Integra LifeSciences | Packaging Defects | Nationwide |
Other Other Medical Devices recalls
All 13,771| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: Blood Draw Kit recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ortho Aspiration Kit recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep DYKA1054F recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Arterial Line Insertion Kit recalled | Medline Industries | Sterility | Nationwide |