Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of large bones and large bone fra

FDA device recall Z-0408-2014 · posted 2013-11-27 · Terminated

Recall details

Recalling firm

Synthes USA HQ, Inc.

Reason for recall

There is a possibility for the Guide Wires of the Slipped Capital Femoral Epiphysis System to stick in the cannulation of the drill bit and the drill bits to break during surgery.

Action taken

Synthes sent an Urgent Notice: Medical Device Recall letter dated July 30, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review their inventory, immediately remove the affected product and return to Credit/Returns, Synthes. For questions call 610-719-5450.

Root cause

Device Design

Status

Terminated

Product code

HTW

Quantity affected

166

Distribution

USA Nationwide Distribution

Date initiated

2013-07-31

Date posted

2013-11-27

Date terminated

2015-06-01

Location

West Chester, PA