PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: April 23, 2014 Initiated: January 30, 2014 #Z-1456-2014

Product Description

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.

Reason for Recall

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.

Details

Recalling Firm
Synthes, Inc.
Units Affected
20081
Distribution
Nationwide Distribution
Location
West Chester, PA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Synthes, Inc.. Units affected: 20081.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 23, 2014. Severity: Moderate. Recall number: Z-1456-2014.