Health Canada — Medical Devices · Canada · 2025-10-22 · Type II
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Reported risk: On April 2025, Integra issued a voluntary recall for the 14mm Codman® Disposable Perforators due to an inadequate weld (proud weld) on specific lots of 14mm Codman® Disposable Perforators that can potentially cause the product to disassemble (break/separate). To date, there have been no complaints or adverse events reported in relation to the 9mm and 11mm Codman® Disposable Perforators disassembly. Out of an abundance of caution, as the 9 and 11 mm perforators are manufactured using the same equipment and operating parameters that affected the 14mm Perforator, Integra has made the decision to expand the scope of the field action to include the 9mm and 11mm perforators.
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