Recall MonitorHealth Products
Henry Schein Maxima Diamonds FG (Burs)
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Dental
Product: Henry Schein Maxima Diamonds FG (Burs)
Issue: Medical devices - Labelling and packaging, Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare, Industry
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Henry Schein Maxima Diamonds FG (Burs) | All lots. | 8782815 |
| Henry Schein Maxima Diamonds FG (Burs) | All lots. | 8782986 |
| Henry Schein Maxima Diamonds FG (Burs) | All lots. | 8783524 |
| Henry Schein Maxima Diamonds FG (Burs) | All lots. | 8783740 |
| Henry Schein Maxima Diamonds FG (Burs) | All lots. | 8782938 |
| Henry Schein Maxima Diamonds FG (Burs) | All lots. | 8782987 |
| Henry Schein Maxima Diamonds FG (Burs) | All lots. | 8783527 |
| Henry Schein Maxima Diamonds FG (Burs) | All lots. | 8782776 |
| Henry Schein Maxima Diamonds FG (Burs) | All lots. | 8782989 |
| Henry Schein Maxima Diamonds FG (Burs) | All lots. | 8783824 |
| Henry Schein Maxima Diamonds FG (Burs) | All lots. | 8782888 |
| Henry Schein Maxima Diamonds FG (Burs) | All lots. | 8782966 |
| Henry Schein Maxima Diamonds FG (Burs) | All lots. | 8783510 |
| Henry Schein Maxima Diamonds FG (Burs) | All lots. | 8783609 |
| Henry Schein Maxima Diamonds FG (Burs) | All lots. | 8783630 |
| Henry Schein Maxima Diamonds FG (Burs) | All lots. | 8783820 |
| Henry Schein Maxima Diamonds FG (Burs) | All lots. | 8788840 |
| Henry Schein Maxima Diamonds FG (Burs) | All lots. | 8782761 |
| Henry Schein Maxima Diamonds FG (Burs) | All lots. | 8782863 |
| Henry Schein Maxima Diamonds FG (Burs) | All lots. | 8782963 |
| Henry Schein Maxima Diamonds FG (Burs) | All lots. | 8782980 |
| Henry Schein Maxima Diamonds FG (Burs) | All lots. | 8783581 |
| Henry Schein Maxima Diamonds FG (Burs) | All lots. | 8783755 |
| Henry Schein Maxima Diamonds FG (Burs) | All lots. | 8783769 |
| Henry Schein Maxima Diamonds FG (Burs) | All lots. | 8782951 |
| Henry Schein Maxima Diamonds FG (Burs) | All lots. | 8782964 |
| Henry Schein Maxima Diamonds FG (Burs) | All lots. | 8782991 |
| Henry Schein Maxima Diamonds FG (Burs) | All lots. | 8783737 |
Issue
Henry Schein Inc. is initiating this field safety notification to inform customers of an important update to the instructions for use (IFU) for their maxima diamond burs. This update provides enhanced guidance on the proper installation and recommended force application during use, aimed at reducing the risk of bur dislodgement during patient procedures. The updated IFU does not alter the device's design or functionality.