Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1155-2021 — ConMed Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.

U.S. FDA — Device Enforcement · United States · 2021-02-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1155-2021
Date of alert
2021-02-01
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Bovie Medical Corporation
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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