FDA Recall Terminated

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.

Recall: Z-1016-2013 · Initiated January 11, 2013

Recall

Recall Number: Z-1016-2013
Event Number: 64271
Firm: Synthes USA HQ, Inc.
FEI Number: 3005180112
Product Code: HWC
Status: Terminated
Root Cause: No Marketing Application
Initiated: January 11, 2013
Posted: March 28, 2013
Terminated: September 10, 2015
Address: 1302 Wrights Ln E, West Chester, PA, 19380-3417

Description

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.

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.

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.

Quantity

148