Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws in the cranialfacial bones, and to drill and/

FDA device recall Z-1456-2014 · posted 2014-04-14 · Terminated

Recall details

Recalling firm

Synthes, Inc.

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.

Action taken

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 the search bar to download the Users Manual Forward this Field Safety Notification to anyone in your facility that needs to be informed. If the graphic case has been forwarded to another facility, contact that facility. " Maintain a copy of this notice. If you have any questions, please call 610-719-5450 or contact your Synthes Sales Consultant. Thank you for your attention to this issue.

Root cause

Labeling design

Status

Terminated

Product code

GXL

Quantity affected

20081

Distribution

Nationwide Distribution

Date initiated

2014-01-30

Date posted

2014-04-14

Date terminated

2016-08-26

Location

West Chester, PA