Z-2061-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 27, 2020
- Initiation Date
- April 20, 2020
- Termination Date
- September 13, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 38,738
Product Description
Renuvion/ J-Plasma Precise Handpiece. Catalog numbers BVX-150B, BVX-270B, BVX-330B, BVX-270BPP, BVX- 330BPS, APYX-150B, APYX-270B, APYX-330B, APYX- 270BPP, and APYX-330BPS. Product Usage: for electrosurgical cutting, coagulation and ablation of soft tissue during open and laparoscopic surgical procedures.
Reason for Recall
Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during clinical use.
Distribution Pattern
Worldwide distribution - US nationwide including in the states of Puerto Rico, and the countries of CA, JO, CO, MX, BR, CR, PA, KW, CL, MA, ES, TH, PH, IQ, LB, DO, Japan, QA, AE, PE, AU, VN, IL, Lithuania, UAE, Belgium, Denmark, Austria, Poland, Germany, Slovakia, Spain, Cyprus, Switzerland, Turkey, UK, Italy, Bulgaria, Greece, Norway, Ireland, Hungary, and Croatia.
Code Information
The following Catalog numbers which were distributed from 06/01/2016 through present: BVX-150B, BVX-270B, BVX-330B, BVX-270BPP, BVX- 330BPS, APYX-150B, APYX-270B, APYX-330B, APYX- 270BPP, APYX-330BPS