13 ft Handpiece Cable — Class II medical device recall Z-2953-2020
Terminated recall by Integra LifeSciences Corp., reported 2020-09-23, distributed nationwide. lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following st
| Recall number | Z-2953-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Princeton, NJ, United States |
| Recall initiated | 2020-08-04 |
| Classified | 2020-09-11 |
| Reported by FDA | 2020-09-23 |
| Terminated | 2021-08-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 74 units |
| Serial numbers | PT-3195 |
| Model numbers | 353971513 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2953-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.