International safety notice
This product supplements the initial fixation of a PS cemented femoral component to the bone in orthopedic knee replacement surgery. This is a product that helps. When we investigated overseas manufacturers, we found that in some lots, the hexagonal hole was not processed at the tip of the peg. Since we cannot deny the possibility that these products may be contaminated, we have decided to carry out a voluntary recall of the affected products.
Japan / PMDA Recalls · JPN · Oct 12, 2023
Key facts
| Title | This product supplements the initial fixation of a PS cemented femoral component to the bone in orthopedic knee replacement surgery. This is a product that helps. When we investigated overseas manufacturers, we found that in some lots, the hexagonal hole was not processed at the tip of the peg. Since we cannot deny the possibility that these products may be contaminated, we have decided to carry out a voluntary recall of the affected products. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: total knee prosthesis Sales name: Triathlon artificial knee joint system PS |
| Manufacturer | Japan Striker Co., Ltd. |
| Models | 5575-X-000, RHC7H, EPB3E |
| Date | Oct 12, 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