International safety notice

We received a report from the market that there was a white foreign substance attached to the inside of the cup of this product. Ta. It turned out that there was a foreign object in the presser cover (PETG material) due to excessive contact between the presser cover (PETG material) and the top of the product. Ta. We have decided to voluntarily recall the product. No information has been reported.

Japan / PMDA Recalls · JPN · Oct 18, 2024

Key facts

Title We received a report from the market that there was a white foreign substance attached to the inside of the cup of this product. Ta. It turned out that there was a foreign object in the presser cover (PETG material) due to excessive contact between the presser cover (PETG material) and the top of the product. Ta. We have decided to voluntarily recall the product. No information has been reported.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: Artificial hip acetabular component Sales name: GS Cup
Manufacturer Teijin Nakashima Medical Co., Ltd.
Models WP332058, WP332048, WP331062, WP331058, WP331042, WP331048, WP332056, WP332050, WP331054, WP332060, WP332054, WP332062 and 10 more
Date Oct 18, 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

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