FDA Device recall Z-1456-2014
Synthes CMF Battery Powered Driver, Part no. 305.840
- FDA Device
- Class II
- terminated
- Published 2014-04-23
On 2014-04-23 the FDA classified a Class II recall of Synthes CMF Battery Powered Driver, Part no. 305.840 by Synthes, citing 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 inten….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1456-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-01-30 |
| Published | 2014-04-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synthes |
| Distribution | US |
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.
Identifiers
| code_info | Part no. 305.840, with lot nos.: 5680577, 5701123, 5713215, 5763130, 5783316, 5787131, 5828296, 6124867, 6136125, 61508…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1456-2014%22
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