Recall Z-1456-2014— Synthes, Inc.
Class II · Terminated
Class II FDA medical device recall by Synthes, Inc., initiated 2014-01-30, terminated 2016-08-26. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- Synthes, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-01-30
- Terminated
- 2016-08-26
- Firm location
- West Chester, PA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.