International safety notice

We have received a report of an incident where the needle storage part was damaged during the procedure and the needle fell into the wound. Although there have been no reports of the same incident occurring at other facilities, we have decided to voluntarily recall the lot in question for safety reasons. Masu.

Japan / PMDA Recalls · JPN · Dec 12, 2024

Key facts

Title We have received a report of an incident where the needle storage part was damaged during the procedure and the needle fell into the wound. Although there have been no reports of the same incident occurring at other facilities, we have decided to voluntarily recall the lot in question for safety reasons. Masu.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common Name: Single Use Surgical Stapler Sales name: Skin stapler
Manufacturer KEISEI MEDICAL INDUSTRY CO., LTD.
Models 200507, WSS-35W
Date Dec 12, 2024
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

Browse all International device safety notices