International safety notice

The facility with a medical device foreign manufacturer registration certificate (design) will expire from March 26, 2020 to July 2, 2020. It was. In violation of the provisions of Article 55, Paragraph 2, which shall apply mutatis mutandis.

Japan / PMDA Recalls · JPN · Jun 12, 2023

Key facts

Title The facility with a medical device foreign manufacturer registration certificate (design) will expire from March 26, 2020 to July 2, 2020. It was. In violation of the provisions of Article 55, Paragraph 2, which shall apply mutatis mutandis.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: Non-absorbable vascular anastomotic coupler Brand name: Microvascular suture device coupler (sterilized)
Manufacturer Diadem Industries Co., Ltd.
Models SP20F12-1457815, SP20D28-1447248, SP20F30-1461195, SP20G16-1464280, GEM2753, SP20E22-1452926, SP20G01-1461477, SP20F11-1457466, GEM2751, SP20F01-1454959, SP20D27-1447137, SP20G07-1462218 and 11 more
Date Jun 12, 2023
Regulator page info.pmda.go.jp

At a glance

  • No Recall
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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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