International safety notice
In the total artificial hip joint (trade name: Ocean artificial hip joint) manufactured and sold by our company, the distal part of the stem is fixed. It has been reported that the adhesive may peel off from the packaging material (cushioning material) and adhere to the stem. Since we cannot deny the possibility that this event may occur, we, as the manufacturer and distributor, are voluntarily recalling the product.
Japan / PMDA Recalls · JPN · Nov 24, 2022
Key facts
| Title | In the total artificial hip joint (trade name: Ocean artificial hip joint) manufactured and sold by our company, the distal part of the stem is fixed. It has been reported that the adhesive may peel off from the packaging material (cushioning material) and adhere to the stem. Since we cannot deny the possibility that this event may occur, we, as the manufacturer and distributor, are voluntarily recalling the product. |
|---|---|
| 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 | HCO404, 490852, 490849, 490896, 22700BZI00012000, 490990, 490981, 490864, 490932, 490993, 490882 |
| Date | Nov 24, 2022 |
| 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