International safety notice
This product is a normal type screw, but some batches from overseas manufacturers have auto drive type screws. We have received a report that a voluntary recall will be conducted because there is a possibility that Ryu may be mixed in. However, we have decided to carry out a voluntary recall of affected products that have already been shipped.
Japan / PMDA Recalls · JPN · Jan 19, 2022
Key facts
| Title | This product is a normal type screw, but some batches from overseas manufacturers have auto drive type screws. We have received a report that a voluntary recall will be conducted because there is a possibility that Ryu may be mixed in. However, we have decided to carry out a voluntary recall of affected products that have already been shipped. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Internal fixation plate Brand name: Osteomed Craniomaxillofacial Plating System |
| Manufacturer | Unimedic Co., Ltd. |
| Models | 1155785, 1156762, 202-2005, 1160313 |
| Date | Jan 19, 2022 |
| 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