International safety notice
Although the manufacturer had relocated, it was discovered that the procedures for changing the manufacturing and sales certificate had not been completed. We will carry out collection.
Japan / PMDA Recalls · JPN · Jun 1, 2023
Key facts
| Title | Although the manufacturer had relocated, it was discovered that the procedures for changing the manufacturing and sales certificate had not been completed. We will carry out collection. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Active extension/flexion/extension rotation exercise device Sales name: Jace Universal CPM System II |
| Manufacturer | Zimmer Biomet LLC |
| Models | K1-0821-3168, K1-0519-2771, K1-0822-3210, K1-0822-3209, K1-0821-3160, K1-0821-3167, K1-0821-3164, K1-0320-2887, K1-0220-2848, K1-0821-3158, K1-0220-2850, K1-0219-2769 and 15 more |
| Date | Jun 1, 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