Z-0781-2013Class II

Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion - 2.5mm Drill...

Name: Z-0781-2013 Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion - 2.5mm Drill...
Creator: Synthes USA HQ, Inc.
Published: 2012-08-06
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2012-08-06 / Terminated / root cause: design

FDA source

Synthes USA HQ, Inc. began a recall of Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion - 2.5mm Drill Bit, graduated 12mm - 26mm adjustable depth, Part... on 2012-08-06. FDA classified it as Class II and gives the reason as "Although the reported incidence is low, there is the potential for the drill stop to slip on the drill bit resulting in an adverse event". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0781-2013
Classification: Class II
Status: Terminated
Initiated: 2012-08-06
Posted: 2013-02-04
Terminated: 2015-08-31
Recalling firm: Synthes GmbH
Product: Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion - 2.5mm Drill Bit, graduated 12mm - 26mm adjustable depth, Part Number 03.613.011. Synthes Vectra System, Synthes Vectra-One System and Synthes Vectra-T System is intended for anterior plate and screw fixation of the cervical spine (C2-C7).
Product code: KWQ Appliance, Fixation, Spinal Intervertebral Body
Reason for recall: Although the reported incidence is low, there is the potential for the drill stop to slip on the drill bit resulting in an adverse event.
Root cause tag: design
FDA root cause: Component design/selection
Action: Synthes sent a "NOTICE: MEDICAL DEVICE RECALL" letter dated August 6, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 610-719-5450 for questions related to this notice.
Quantity in commerce: 63
Distribution: Nationwide Distribution-including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY.
Product codes and lots: 2.5mm Drill Bit, graduated 12mm - 26mm adjustable depth, Part Number 03.613.011 - Lots 5443576, 5522810, 5537042, 5557902

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0781-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0781-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-13	2013-02-04
Z-0782-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-13	2013-02-04

Product code KWQ

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)