Restoration Anatomic Shell (2020-04-16)
Recall Summary Restoration Anatomic Shell devices are being recalled across Canada due to issues with the medical device itself. This recall affects all units of this product that were distributed in Canada. The FDA has classified this as a Class I recall, which is the most serious type.
- Reason
- Medical devices
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DEVICES
- Recall date
- 2020-05-01
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/115aeb1d-b6f6-47af-9519-3ef8c81506e8