International safety notice

As a result of a complaint investigation conducted by an overseas manufacturer, certain manufactured cereals were found to be contaminated under high temperatures during sterilization at the facility where they were used. We have decided to voluntarily recall the product because it was discovered that the handle of the product may be deformed.

Japan / PMDA Recalls · JPN · Sep 1, 2023

Key facts

Title As a result of a complaint investigation conducted by an overseas manufacturer, certain manufactured cereals were found to be contaminated under high temperatures during sterilization at the facility where they were used. We have decided to voluntarily recall the product because it was discovered that the handle of the product may be deformed.
Regulator Japan / PMDA Recalls
Country JPN
Brand General name: Instruments for bone surgery Sales name: EM Instrument
Manufacturer Brain Lab Co., Ltd.
Models 1594322221, 1533820086, 1533820080, 1594322134, 1594322115, 1594322084, 1594322235, 1533820107, 1533820088, 1594322279, 1533820075, 18099-02C and 21 more
Date Sep 1, 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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