International safety notice

Products manufactured in a registered manufacturing facility that performs the main assembly and sterilization process for which some changes have not been completed in the marketing approval. Because it was shipped to the market.

Japan / PMDA Recalls · JPN · Nov 8, 2023

Key facts

Title Products manufactured in a registered manufacturing facility that performs the main assembly and sterilization process for which some changes have not been completed in the marketing approval. Because it was shipped to the market.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: Staple for internal fixation Brand name: Staple for ligament fixation
Manufacturer Arthrex Japan Contract Co., Ltd.
Models AR-1008, 118413
Date Nov 8, 2023
Regulator page info.pmda.go.jp

At a glance

  • No Recall
  • No Field safety notice
  • 1–9 Matching device models in FDA data
  • 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