Health product recall

Henry Schein Maxima Diamonds FG (Burs)

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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