Z-1456-2014Class II

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

Name: Z-1456-2014 Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws in the cranialfacial bones, and to...
Creator: Synthes, Inc.
Published: 2014-01-30
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2014-01-30 / Terminated / root cause: labeling and UDI

FDA source

Synthes, Inc. began a recall of 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... on 2014-01-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1456-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-30
Posted: 2014-04-14
Terminated: 2016-08-26
Recalling firm: Synthes GmbH
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.
Product code: GXL Screwdriver, Skullplate
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.
Root cause tag: labeling and UDI
FDA 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 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.
Quantity in commerce: 20081
Distribution: Nationwide Distribution
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1456-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1456-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-23	2014-04-14

Product code GXL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)