Recall Z-1016-2013— Synthes USA HQ, Inc.
Class II · Terminated
Class II FDA medical device recall by Synthes USA HQ, Inc., initiated 2013-01-11, terminated 2015-09-10. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Synthes USA HQ, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-01-11
- Terminated
- 2015-09-10
- Firm location
- West Chester, PA, United States
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.
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.
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