International safety notice
This product is a stem head used on the femoral side to replace the hip joint function during hip replacement surgery. Combined with the femoral stem to form the femoral component, the product is used with the acetabular component. I will. In Japan and overseas, "When I opened the box with the neck length written as +4mm on the product box label, I found that the neck length of the same product was -4mm. long products It was packed. Department product lot It was discovered that an incorrect label had been attached due to a worker's error. Therefore, we cannot deny the possibility that the box label and the actual product do not match, so we have decided to implement a voluntary recall of the affected products. did.
Japan / PMDA Recalls · JPN · Feb 7, 2022
Key facts
| Title | This product is a stem head used on the femoral side to replace the hip joint function during hip replacement surgery. Combined with the femoral stem to form the femoral component, the product is used with the acetabular component. I will. In Japan and overseas, "When I opened the box with the neck length written as +4mm on the product box label, I found that the neck length of the same product was -4mm. long products It was packed. Department product lot It was discovered that an incorrect label had been attached due to a worker's error. Therefore, we cannot deny the possibility that the box label and the actual product do not match, so we have decided to implement a voluntary recall of the affected products. did. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Prosthetic hip femoral component Sales name: BIOLOX delta ceramic femoral head |
| Manufacturer | Japan Striker Co., Ltd. |
| Models | 89546202, 89648801, 6570-0-232, 89648803, 89648802, 89648804, 6570-0-032 |
| Date | Feb 7, 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