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Henry schein maxima diamonds fg (burs)

Official notice

13 Nov 2025

Last checked

13 Nov 2025

Medium riskHealth Canada

An official Health Canada notice concerns Henry schein maxima diamonds fg (burs). 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. Published 2025-11-13.

What to do now

Contact the manufacturer if you require additional information.

Recall number

81214

Official notice

2025-11-13

The hazard

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.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

81214

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Affected products

Product 1

Affected products - Henry Schein Maxima Diamonds FG (Burs), Lot or serial number - All lots., Model or catalogue number - 8782815

Product 2

Affected products - Henry Schein Maxima Diamonds FG (Burs), Lot or serial number - All lots., Model or catalogue number - 8782986

Product 3

Affected products - Henry Schein Maxima Diamonds FG (Burs), Lot or serial number - All lots., Model or catalogue number - 8783524

Product 4

Affected products - Henry Schein Maxima Diamonds FG (Burs), Lot or serial number - All lots., Model or catalogue number - 8783740

Product 5

Affected products - Henry Schein Maxima Diamonds FG (Burs), Lot or serial number - All lots., Model or catalogue number - 8782938

Product 6

Affected products - Henry Schein Maxima Diamonds FG (Burs), Lot or serial number - All lots., Model or catalogue number - 8782987

Product 7

Affected products - Henry Schein Maxima Diamonds FG (Burs), Lot or serial number - All lots., Model or catalogue number - 8783527

Product 8

Affected products - Henry Schein Maxima Diamonds FG (Burs), Lot or serial number - All lots., Model or catalogue number - 8782776

Product 9

Affected products - Henry Schein Maxima Diamonds FG (Burs), Lot or serial number - All lots., Model or catalogue number - 8782989

Product 10

Affected products - Henry Schein Maxima Diamonds FG (Burs), Lot or serial number - All lots., Model or catalogue number - 8783824

Product 11

Affected products - Henry Schein Maxima Diamonds FG (Burs), Lot or serial number - All lots., Model or catalogue number - 8782888

Product 12

Affected products - Henry Schein Maxima Diamonds FG (Burs), Lot or serial number - All lots., Model or catalogue number - 8782966

Product 13

Affected products - Henry Schein Maxima Diamonds FG (Burs), Lot or serial number - All lots., Model or catalogue number - 8783510

Product 14

Affected products - Henry Schein Maxima Diamonds FG (Burs), Lot or serial number - All lots., Model or catalogue number - 8783609

Product 15

Affected products - Henry Schein Maxima Diamonds FG (Burs), Lot or serial number - All lots., Model or catalogue number - 8783630

Product 16

Affected products - Henry Schein Maxima Diamonds FG (Burs), Lot or serial number - All lots., Model or catalogue number - 8783820

Product 17

Affected products - Henry Schein Maxima Diamonds FG (Burs), Lot or serial number - All lots., Model or catalogue number - 8788840

Product 18

Affected products - Henry Schein Maxima Diamonds FG (Burs), Lot or serial number - All lots., Model or catalogue number - 8782761

Product 19

Affected products - Henry Schein Maxima Diamonds FG (Burs), Lot or serial number - All lots., Model or catalogue number - 8782863

Product 20

Affected products - Henry Schein Maxima Diamonds FG (Burs), Lot or serial number - All lots., Model or catalogue number - 8782963

Product 21

Affected products - Henry Schein Maxima Diamonds FG (Burs), Lot or serial number - All lots., Model or catalogue number - 8782980

Product 22

Affected products - Henry Schein Maxima Diamonds FG (Burs), Lot or serial number - All lots., Model or catalogue number - 8783581

Product 23

Affected products - Henry Schein Maxima Diamonds FG (Burs), Lot or serial number - All lots., Model or catalogue number - 8783755

Product 24

Affected products - Henry Schein Maxima Diamonds FG (Burs), Lot or serial number - All lots., Model or catalogue number - 8783769

Product 25

Affected products - Henry Schein Maxima Diamonds FG (Burs), Lot or serial number - All lots., Model or catalogue number - 8782951

Product 26

Affected products - Henry Schein Maxima Diamonds FG (Burs), Lot or serial number - All lots., Model or catalogue number - 8782964

Product 27

Affected products - Henry Schein Maxima Diamonds FG (Burs), Lot or serial number - All lots., Model or catalogue number - 8782991

Product 28

Affected products - Henry Schein Maxima Diamonds FG (Burs), Lot or serial number - All lots., Model or catalogue number - 8783737

Risk / hazard

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.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Henry Schein, Henry Schein Maxima Diamonds Fg.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

81214

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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