FDA-Device2015-07-01Class II
ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012. Drill Guides are used to interface with various drill tips during the drilling procedure of bone preparation.
Orthofix, Inc
Hazard
There is a possibility that the thumb button remains in the depressed (unlocked) position allowing the threaded sleeve (drill stop) to unintentionally rotate and change the depth setting.
Sold states
Nationwide Distribution including CA, VA, FL, ID, CO, OR, PA, OK, SC, and TX.
Affected count
36 units
Manufactured in
3451 Plano Pkwy, Lewisville, TX, United States
Products
ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012. Drill Guides are used to interface with various drill tips during the drilling procedure of bone preparation.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1819-2015Don't want to check this manually?
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