International safety notice

It was discovered that the legal label and package insert for a different product had been attached to the product, so we have taken action. We have decided to carry out a voluntary recall of elephant products.

Japan / PMDA Recalls · JPN · Jan 31, 2022

Key facts

Title It was discovered that the legal label and package insert for a different product had been attached to the product, so we have taken action. We have decided to carry out a voluntary recall of elephant products.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: Artificial inner ear Sales name: Nucleus CP810 Sound Processor
Manufacturer Cochlear Japan Co., Ltd.
Models 1010098278432, 1010098276179, 1010098275745
Date Jan 31, 2022
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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