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Recall Observatory FDA recall evidence

Device 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.

Z-1016-2013

January 11, 2013

Class II

Product summary

Firm
Synthes USA HQ, Inc.
Event
Event 64271
Status
Terminated
Classification
Class II
Quantity
148
Official record key
device-enforcement:Z-1016-2013

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.

Field note

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