International safety notice

We have not applied for a QMS compliance investigation for the item manufactured and sold by our company since February 2009, and it is properly QMS compliant. It turned out that she had not undergone a sex survey. Due to this possibility, we have decided to carry out a voluntary recall.

Japan / PMDA Recalls · JPN · Nov 15, 2022

Key facts

Title We have not applied for a QMS compliance investigation for the item manufactured and sold by our company since February 2009, and it is properly QMS compliant. It turned out that she had not undergone a sex survey. Due to this possibility, we have decided to carry out a voluntary recall.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: Dental endosseous implant material Brand name: Oga Implant
Manufacturer Detech Co., Ltd.
Date Nov 15, 2022
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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