International safety notice

The orbital retractor is an orbital retractor that protects the orbital soft tissue and determines the size of the defect. Some products were found to have burrs on the outside of the hole. The manufacturer (Medartis AG) has instructed us to recall this product due to its harmful effects, so we have conducted a voluntary recall of this product.

Japan / PMDA Recalls · JPN · Apr 6, 2023

Key facts

Title The orbital retractor is an orbital retractor that protects the orbital soft tissue and determines the size of the defect. Some products were found to have burrs on the outside of the hole. The manufacturer (Medartis AG) has instructed us to recall this product due to its harmful effects, so we have conducted a voluntary recall of this product.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: Creator Sales name: MODUS2 Retractor
Manufacturer Gunze Medical Co., Ltd.
Date Apr 6, 2023
Regulator page info.pmda.go.jp

At a glance

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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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