International safety notice

This product is used in conjunction with a bipolar generator to coagulate biological tissue using high-frequency current. This product is used for surgery. As a result of an investigation by an overseas manufacturer, it was discovered that the product had been printed for a long time, so the company decided to voluntarily recall the affected products. Did.

Japan / PMDA Recalls · JPN · Sep 11, 2023

Key facts

Title This product is used in conjunction with a bipolar generator to coagulate biological tissue using high-frequency current. This product is used for surgery. As a result of an investigation by an overseas manufacturer, it was discovered that the product had been printed for a long time, so the company decided to voluntarily recall the affected products. Did.
Regulator Japan / PMDA Recalls
Country JPN
Brand General name: バイポーラ electrode Sales name: Spetzler Maris Bipolar Forceps
Manufacturer Japan Striker Co., Ltd.
Models 201126013, 6770-230-005, 201001029, 6770-200-005, 6780-200-005-1, 200924012, 6780-230-005, 201008013, 201022005, 201203014, 200806012, 201008016 and 6 more
Date Sep 11, 2023
Regulator page info.pmda.go.jp

At a glance

  • No Recall
  • No Field safety notice

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About International device safety notices

Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.

Source: National medical device regulators (as listed), compiled by Orca1

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