International safety notice

This product is an intramedullary nail implant used in femoral fracture fixation surgery. When a different product was confirmed and an investigation was conducted at the overseas manufacturer, it was discovered that a similar phenomenon had occurred in the product of the target lot. It has become clear that there is a possibility that

Japan / PMDA Recalls · JPN · Feb 2, 2023

Key facts

Title This product is an intramedullary nail implant used in femoral fracture fixation surgery. When a different product was confirmed and an investigation was conducted at the overseas manufacturer, it was discovered that a similar phenomenon had occurred in the product of the target lot. It has become clear that there is a possibility that
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: Femoral intramedullary nail for internal fixation Brand name: TFNA Proximal Femoral Nail System
Manufacturer Johnson & Johnson Co., Ltd.
Models 04-037-213S, 04-037-212S, 611P035, 607P512
Date Feb 2, 2023
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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