International safety notice
For our nail system, we put cushioning material and attached documents in the individual packaging box to suppress the vibration of the product. However, it was confirmed that foreign matter had gotten into the gaps between the cushioning materials. Because we cannot deny the possibility that this may have occurred, we have decided to voluntarily recall all affected lots.
Japan / PMDA Recalls · JPN · Sep 8, 2022
Key facts
| Title | For our nail system, we put cushioning material and attached documents in the individual packaging box to suppress the vibration of the product. However, it was confirmed that foreign matter had gotten into the gaps between the cushioning materials. Because we cannot deny the possibility that this may have occurred, we have decided to voluntarily recall all affected lots. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Femoral intramedullary nail for internal fixation Sales name: OM Femoral Nail System III |
| Manufacturer | Ohmic Co., Ltd. |
| Models | MD2210060008, NH12-125XA |
| Date | Sep 8, 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