Recall Z-1456-2014 ยท GXL Screwdriver, Skullplate
Synthes, Inc.
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.
| Date | Apr 14, 2014 (initiated Jan 30, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Labeling design |
| Action | Synthes sent an Urgent Notice: Field Safety Notification letter dated January 30, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please take the following actions; Please see the Battery Powered Driver Users Manual for on-label procedures. You can access an electronic version of the Battery Powered Driver Users Manual by accessing the following : linlc http://www.synthes.com/pages/default.aspx. Click on North America Tab at the top of the screen, and then type Battery Powered Driver Users Manual in t |
| Quantity | 20081 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.