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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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.
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