International safety notice
A product with a different size than the size stated on the product label and the size of the packaged product has been discovered overseas, and this may affect the product. We have decided to carry out a voluntary recall of products that may have been contaminated.
Japan / PMDA Recalls · JPN · May 17, 2023
Key facts
| Title | A product with a different size than the size stated on the product label and the size of the packaged product has been discovered overseas, and this may affect the product. We have decided to carry out a voluntary recall of products that may have been contaminated. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Prosthetic hip femoral component Sales name: RIM-LOCK BioloxR delta femoral head |
| Manufacturer | Microport Orthopedics Japan Co., Ltd. |
| Models | PHA04402, 1952019, 1952018 |
| Date | May 17, 2023 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 Matching catalog numbers in FDA data
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