Z-1016-2013Class II

Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also known as the Anterior Column...

Name: Z-1016-2013 Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also known as the Anterior Column...
Creator: Synthes USA HQ, Inc.
Published: 2013-01-11
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2013-01-11 / Terminated

FDA source

Synthes USA HQ, Inc. began a recall of Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also known as the Anterior Column Retractor Set) The Synthes Dens instrument Set has been... on 2013-01-11. FDA classified it as Class II and gives the reason as "The Dens Instrument Set has been designed to facilitate the anterior internal fixation of the Dens (odontoid process). There are currently no screws specifically indicated to treat Dens fractures via anterior screw...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1016-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-11
Posted: 2013-03-28
Terminated: 2015-09-10
Recalling firm: Synthes GmbH
Product: Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also known as the Anterior Column Retractor Set) The Synthes Dens instrument Set has been designed to facilitate internal fixation of the odontoid process for the reduction of Type II and shallow Type III fractures, as proposed by Anderson and d'Alonzo.
Product code: HWC Screw, Fixation, Bone
Reason for recall: The Dens Instrument Set has been designed to facilitate the anterior internal fixation of the Dens (odontoid process). There are currently no screws specifically indicated to treat Dens fractures via anterior screw fixation therefore the affected product will be removed.
FDA root cause: No Marketing Application
Action: Synthes sent an Urgent Notice Medical Device Recall letter dated January 11, 2013, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to examine their inventory, remove the recalled product from use and return it to Synthes. Customers were asked to completed the attached verification Section at the end of the letter by checking the appropriate box indicating that no affected product had been located and fax to 610-251-9005. For questions customers were instructed to call 610-719-5450 or email at [email protected]. For questions regarding this recall call 610-719-5000.
Quantity in commerce: 148
Distribution: Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DE, FL, GA, IL, KS, KY, LA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OR, PA, RI, TN, TX, VA, VT, WI, WV, and WY.
Product codes and lots: Part number 687.030, All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1016-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1016-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-03	2013-03-28

Product code HWC

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

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

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)