International safety notice

It was discovered that some of the products in the target lot had incorrect product numbers and lengths stamped on them, so we are issuing a voluntary recall. We have decided to implement it. Product number Length Positive: 18157540 40 Error: 18157545 45

Japan / PMDA Recalls · JPN · Jul 28, 2023

Key facts

Title It was discovered that some of the products in the target lot had incorrect product numbers and lengths stamped on them, so we are issuing a voluntary recall. We have decided to implement it. Product number Length Positive: 18157540 40 Error: 18157545 45
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: spinal internal fixation device Sales name: Elisma LP
Manufacturer Biogenesis Co., Ltd.
Models NCH3X
Date Jul 28, 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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