International safety notice
The shape of the groove on the plate was changed due to a change in the product configuration, but it was different from what was written in the manufacturing and sales approval. We have decided to voluntarily recall the affected lots of products that have already been shipped to the market.
Japan / PMDA Recalls · JPN · Jun 16, 2023
Key facts
| Title | The shape of the groove on the plate was changed due to a change in the product configuration, but it was different from what was written in the manufacturing and sales approval. We have decided to voluntarily recall the affected lots of products that have already been shipped to the market. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: spinal internal fixation device Sales name: XTEND Cervical Plate System |
| Manufacturer | Globus Medical Co., Ltd. |
| Models | FCV081AC, FCX352UC, FCW360CC, 161.256, FCA106EC, FCX274DC, FCX352RC, CY292TC, FCV165RC, FCV165BC, FCY263FC, FCV238KC and 645 more |
| Date | Jun 16, 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