International safety notice

Domestic medical institutions have notified us that the specifications differ from those displayed on individual packaging boxes. Upon receiving information that the product was in the package, we investigated. There is a possibility that products from a particular lot may have been mixed up. It turns out. Therefore, we will voluntarily recall the products with the relevant serial numbers.

Japan / PMDA Recalls · JPN · Apr 27, 2021

Key facts

Title Domestic medical institutions have notified us that the specifications differ from those displayed on individual packaging boxes. Upon receiving information that the product was in the package, we investigated. There is a possibility that products from a particular lot may have been mixed up. It turns out. Therefore, we will voluntarily recall the products with the relevant serial numbers.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: Single-use endoscopic stone removal forceps Brand name: Zemex Crusher Catheter M
Manufacturer Zeon Medical Co., Ltd.
Models LBMT420, 210331T1
Date Apr 27, 2021
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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