International safety notice

The product (Bone Profiler 5.0 (for 3.3mm)) is used with a special pin as the axis, but there is a problem with the formation. Because it was discovered that the pin may not fit, all products in that lot will be recalled.

Japan / PMDA Recalls · JPN · Aug 9, 2023

Key facts

Title The product (Bone Profiler 5.0 (for 3.3mm)) is used with a special pin as the axis, but there is a problem with the formation. Because it was discovered that the pin may not fit, all products in that lot will be recalled.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: Surgical medicament Sales name: Camlog Bone Profiler
Manufacturer Altadent Co., Ltd.
Models 0010125131, J5003.3350, 0010130452
Date Aug 9, 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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