International safety notice

The general name of this product is "Electric Dental File", but the product number "NRT-GPR" has a different general name. An internal inspection revealed that the purpose of use of the product (electric dental spiral remover) was declared. We will carry out a voluntary recall of products that include the product number.

Japan / PMDA Recalls · JPN · May 26, 2021

Key facts

Title The general name of this product is "Electric Dental File", but the product number "NRT-GPR" has a different general name. An internal inspection revealed that the purpose of use of the product (electric dental spiral remover) was declared. We will carry out a voluntary recall of products that include the product number.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: Electric dental file Sales name: Manny NRT File
Manufacturer Manny Co., Ltd.
Models H19J0733, H15E057100, H19E127700, H20B111300, H20G113900, H19A031400, H19J073100, H17D1107, H18H000500, H17G020600, H15A046800, H19D079600 and 572 more
Date May 26, 2021
Regulator page info.pmda.go.jp

At a glance

  • No Recall
  • No Field safety notice
  • 1–9 Matching catalog numbers in FDA data

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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

Browse all International device safety notices