Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Synthes CMF Battery Powered Driver Recalled by Synthes, Inc. Due to The CMF Battery Powered Driver graphic case contains...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Synthes, Inc. directly.
Affected 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.
Quantity: 20081
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Synthes, Inc.
Synthes, Inc. has 43 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report