FDA-Device2014-04-23Class II
Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws in the cranialfacial bones, and to drill and/or tap holes to prepare cranialfacial bones for screw insertion.
Synthes, Inc.
Hazard
The CMF Battery Powered Driver graphic case contains outlines of the Battery Powered Driver, taps, screwdriver blades, and a screw holding sleeve. However, the device is not intended to be used in conjunction with a tap for tapping holes in a patient's skull, upper and/or lower jaw. Therefore some outlines in the graphic case suggest a potential use of this device that is considered off-label.
Sold states
Nationwide Distribution
Affected count
20081
Manufactured in
1302 Wrights Ln E, N/A, West Chester, PA, United States
Products
Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws in the cranialfacial bones, and to drill and/or tap holes to prepare cranialfacial bones for screw insertion.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1456-2014Don't want to check this manually?
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