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

FDA device recall Z-1016-2013 · posted 2013-03-28 · Terminated

Recall details

Recalling firm

Synthes USA HQ, Inc.

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.

Action taken

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 FieldAction@synthes.com. For questions regarding this recall call 610-719-5000.

Root cause

No Marketing Application

Status

Terminated

Product code

HWC

Quantity affected

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.

Date initiated

2013-01-11

Date posted

2013-03-28

Date terminated

2015-09-10

Location

West Chester, PA