Henry Schein Maxima Diamonds FG (Burs)
Brand(s)
Last updated
Summary
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
Affected 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.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Dental
Companies
Henry Schein Inc.
135 Duryea Road, Melville, New York, United States, 11747
Published by
Health Canada
Audience
Healthcare
Industry
Recall class
Type II
Recall date
Identification number
RA-81214
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