Z-2915-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 12, 2016
- Initiation Date
- September 19, 2016
- Termination Date
- December 13, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17 systems
Product Description
VariaBreeze; Catalog number: 7300-0035-2. Podiatry: ablation, vaporization, incision, excision, and coagulation of soft tissue including matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neuromas. The temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)
Reason for Recall
FDA inspection found that customers who had received devices with promotional material with outside use indications were not notified when labeling was revised to remove these indications.
Distribution Pattern
US distribution only.
Code Information
Serial numbers: XSB02-VB AESB01 AHSF02 AHSF04 AHSF05 AHSF06 AHSF07 AHSF08 AHTE01 AHSF03 AHTF01 AHTF02 AHTH01 AHTM02 AHTM01 AHTS01 AHTS03.