International safety notice

In Japan and overseas, the catalog number of the product's legal display label (overseas manufacturer's label) and packaging A complaint was filed stating that the product is different. Based on the results of an investigation at an overseas manufacturer, it has been determined that some product lots may have been misplaced during the manufacturing process. I made it clear.

Japan / PMDA Recalls · JPN · Jun 16, 2021

Key facts

Title In Japan and overseas, the catalog number of the product's legal display label (overseas manufacturer's label) and packaging A complaint was filed stating that the product is different. Based on the results of an investigation at an overseas manufacturer, it has been determined that some product lots may have been misplaced during the manufacturing process. I made it clear.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: Single-use bone surgery instrument Brand name: T2 SPI single-use surgical instrument
Manufacturer Japan Striker Co., Ltd.
Models K03CC50, 18061407S, K03CC4F, 18061406S
Date Jun 16, 2021
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