CanadaHenry Schein Maxima Diamonds FG burs (catalogue numbers include 8782815, 8782986, 8783524, 8783740 and others; all lots) are affected. The manufacturer issued an updated instructions for use providing enhanced guidance on proper installation and recommended force to reduce the risk of bur dislodgement during patient procedures; the update does not change the device’s design or functionality. Contact Henry Schein Inc. for additional information.
What's being recalled
Companies: Henry Schein Inc., 135 Duryea Road, Melville, New York, United States, 11747.
How to identify it
Affected products: Henry Schein Maxima Diamonds FG (Burs); Lot or serial number: All lots.; Model or catalogue number: 8782815
Affected products: Henry Schein Maxima Diamonds FG (Burs); Lot or serial number: All lots.; Model or catalogue number: 8782986
Affected products: Henry Schein Maxima Diamonds FG (Burs); Lot or serial number: All lots.; Model or catalogue number: 8783524
Affected products: Henry Schein Maxima Diamonds FG (Burs); Lot or serial number: All lots.; Model or catalogue number: 8783740
Affected products: Henry Schein Maxima Diamonds FG (Burs); Lot or serial number: All lots.; Model or catalogue number: 8782938
Affected products: Henry Schein Maxima Diamonds FG (Burs); Lot or serial number: All lots.; Model or catalogue number: 8782987
Affected products: Henry Schein Maxima Diamonds FG (Burs); Lot or serial number: All lots.; Model or catalogue number: 8783527
Affected products: Henry Schein Maxima Diamonds FG (Burs); Lot or serial number: All lots.; Model or catalogue number: 8782776
Affected products: Henry Schein Maxima Diamonds FG (Burs); Lot or serial number: All lots.; Model or catalogue number: 8782989
Affected products: Henry Schein Maxima Diamonds FG (Burs); Lot or serial number: All lots.; Model or catalogue number: 8783824
Affected products: Henry Schein Maxima Diamonds FG (Burs); Lot or serial number: All lots.; Model or catalogue number: 8782888
Affected products: Henry Schein Maxima Diamonds FG (Burs); Lot or serial number: All lots.; Model or catalogue number: 8782966
Affected products: Henry Schein Maxima Diamonds FG (Burs); Lot or serial number: All lots.; Model or catalogue number: 8783510
Affected products: Henry Schein Maxima Diamonds FG (Burs); Lot or serial number: All lots.; Model or catalogue number: 8783609
Affected products: Henry Schein Maxima Diamonds FG (Burs); Lot or serial number: All lots.; Model or catalogue number: 8783630
Affected products: Henry Schein Maxima Diamonds FG (Burs); Lot or serial number: All lots.; Model or catalogue number: 8783820
Affected products: Henry Schein Maxima Diamonds FG (Burs); Lot or serial number: All lots.; Model or catalogue number: 8788840
Affected products: Henry Schein Maxima Diamonds FG (Burs); Lot or serial number: All lots.; Model or catalogue number: 8782761
Affected products: Henry Schein Maxima Diamonds FG (Burs); Lot or serial number: All lots.; Model or catalogue number: 8782863
Affected products: Henry Schein Maxima Diamonds FG (Burs); Lot or serial number: All lots.; Model or catalogue number: 8782963
Affected products: Henry Schein Maxima Diamonds FG (Burs); Lot or serial number: All lots.; Model or catalogue number: 8782980
Affected products: Henry Schein Maxima Diamonds FG (Burs); Lot or serial number: All lots.; Model or catalogue number: 8783581
Affected products: Henry Schein Maxima Diamonds FG (Burs); Lot or serial number: All lots.; Model or catalogue number: 8783755
Affected products: Henry Schein Maxima Diamonds FG (Burs); Lot or serial number: All lots.; Model or catalogue number: 8783769
Affected products: Henry Schein Maxima Diamonds FG (Burs); Lot or serial number: All lots.; Model or catalogue number: 8782951
Affected products: Henry Schein Maxima Diamonds FG (Burs); Lot or serial number: All lots.; Model or catalogue number: 8782964
Affected products: Henry Schein Maxima Diamonds FG (Burs); Lot or serial number: All lots.; Model or catalogue number: 8782991
Affected products: Henry Schein Maxima Diamonds FG (Burs); Lot or serial number: All lots.; Model or catalogue number: 8783737
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States