CLASS II Device recall · Reported 23 Apr 2014 · FDA Enforcement Report
CMF Battery Powered Driver recalled by Synthes
Synthes is recalling Synthes CMF Battery Powered Driver, distributed nationwide in the US. The recall was initiated on 30 Jan 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1456-2014
- FDA event ID
- 67499
- Recalling firm
- Synthes, West Chester, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Jan 2014
- FDA classified
- 14 Apr 2014
- Reported
- 23 Apr 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 30 Jan 2014 | Recall initiated by company | |
| 14 Apr 2014 | Classified by FDA | +74 days |
| 23 Apr 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Nationwide Distribution
Questions about this recall
Is CMF Battery Powered Driver recalled?
Yes. Synthes recalled CMF Battery Powered Driver on 30 Jan 2014. The recall is Class II and its status is Terminated. Recall number Z-1456-2014.
Why was it 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 lots are affected?
Part no. 305.840, with lot nos.: 5680577, 5701123, 5713215, 5763130, 5783316, 5787131, 5828296, 6124867, 6136125, 6150803, 6167974, 6167975, 6218358, 6222322, 6258395, 6365430, 6365431, 6390225, 6425013, 6456634, 6487035, 6556704, 6624880, 6650136, 6668870, 6743859, 6844968, 6926708, 6983799, 7008819, 7038706, 7221395, 7138319.
Where was it sold?
Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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