ConMed Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.
- Company
- Bovie Medical Corporation
- Recall Initiated
- February 1, 2021
- Recall Number
- Z-1155-2021
- Quantity
- 5270 units
- Firm Location
- Clearwater, FL
Reason for Recall
There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.
Distribution
US Nationwide distribution in the states of CA and FL.
Lot / Code Info
Catalog Numbers C3390A (lots 0317F, 0417B, 0517B, 0517D, 0517J, 0617D, 0617F, 0617H, 0617K, 0717A, 0717G, 0817B, 0917G, 0917J, 1017C, 1017E, 1017J, 1117B, 0418C); C3350A (lots 0317F, 0417B, 0517B, 0517G, 0717C, 0817D, 0917C, 0917E); C3350NA (lots 0317F, 0517G, 0817F); C2455NA (lots 0317F, 0517B, 0717E, 1017C, 1017E); C1860NA (lots 0317F, 0517B, 0717E, 0817F, 1017G, 0418E); C3390NA (lots 0317F, 0517G, 0817H, 1017J, 0418E, 0518F, 1218C).
Root Cause
Device Design
Action Taken
The firm sent "URGENT MEDICAL DEVICE RECALL" (FA-2021-1) and response form to customers on February 1, 2021.