International safety notice

We have identified a product that is incorrectly labeled as 13 instead of 1 on the legal label, so we are self-imposed. I decided to collect the main item.

Japan / PMDA Recalls · JPN · May 25, 2021

Key facts

Title We have identified a product that is incorrectly labeled as 13 instead of 1 on the legal label, so we are self-imposed. I decided to collect the main item.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: plastic suture Sales name: Disposable kit with fiber wire*
Manufacturer Arthrex Japan Contract Co., Ltd.
Models 11535784, AR-1530DS
Date May 25, 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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