Synthes USA HQ, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1016-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: January 11, 2013

Date Posted: April 3, 2013

Recall Number: Z-1016-2013

Event ID: 64271

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.

Status: Terminated

Product Quantity: 148

Code Information:

Part number 687.030, All Lots

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated