Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
Reason for recall: Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use. Distribution: Worldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan. Quantity: 93 units Lot/code info: Model: 3005PK; UDI: 00821925036000; Lot Numbers: All unexpired;
00821925036000
Official record: FDA (Device enforcement) ↗
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