International safety notice

For eligible products, a standard size 6 product must be packed in a standard size 5 container. was discovered, and the medical institution contacted us to inform us that an event had occurred that delayed the surgery. As a result of checking the manufacturing records and interviewing the workers at the above foreign manufacturing facility, we found that the All products have been identified, and the only products on the domestic market that we have been contacted about are the only products that we have contacted, and we have decided to carry out a voluntary recall. Ta.

Japan / PMDA Recalls · JPN · May 8, 2023

Key facts

Title For eligible products, a standard size 6 product must be packed in a standard size 5 container. was discovered, and the medical institution contacted us to inform us that an event had occurred that delayed the surgery. As a result of checking the manufacturing records and interviewing the workers at the above foreign manufacturing facility, we found that the All products have been identified, and the only products on the domestic market that we have been contacted about are the only products that we have contacted, and we have decided to carry out a voluntary recall. Ta.
Regulator Japan / PMDA Recalls
Country JPN
Brand General name: Total artificial hip joint Sales name: Ocean artificial hip joint
Manufacturer Colin Japan Co., Ltd.
Models 489127, 22700BZI00012000, HCO405
Date May 8, 2023
Regulator page info.pmda.go.jp

At a glance

  • No Recall
  • No Field safety notice

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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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