Recall Z-2061-2020 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Bovie Medical Corporation
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.
| Date | Apr 20, 2020 |
| Status | Terminated |
| Reason | Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during clinical use. |
| Root cause | Under Investigation by firm |
| Action | On April 23, 2020 Apyx Medical (Formerly Bovie Medical) sent out an URGENT Medical Device Field Safety Notice identifying the problem, under what circumstances it can occur, the actions that should be taken by the customer/user in order to prevent risk to patients/users, and the actions planned by Apyx Medical to correct the problem. PRODUCTS: All lots of the Renuvion/J-Plasma Precise Hand piece with specified Catlog #'s that are not expired, and all lots of the Renuvion/J-Plasma Precise Open Handpiece with specified Catlog #'s that are not expired. ACTIONS TO BE TAKEN BY CUSTOMER/USER: Foll |
| Quantity | 38,738 |
| Distribution | 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, |
| FDA record | Open on fda.gov |