Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part number 03.010.048) and the

FDA device recall Z-1281-2015 · posted 2015-03-16 · Terminated

Recall details

Recalling firm

Synthes, Inc.

Reason for recall

For certain lots, the incorrect raw material of annealed 17-4PH Stainless Steel was used instead of the correct material of heat-treated 304 Stainless Steel. This may lead to stress-corrosion cracking, which can lead to surgical delay or unintended debris entering the surgical site.

Action taken

An Urgent Notice: Medical Device Recall, dated February 17, 2015, was sent to all direct consignees and sales consultants instructing them to take the following actions: Take note of the quantity of affected parts in your possession, and then follow ONE of the options for replacement of the affected product: Option 1: Call DePuy Synthes Repair Department at 1-800-288-6698 to schedule a repair for the affected products. Complete the Verification Section following the instructions provided and send a copy of the completed Verification Section to DePuy Synthes by: Fax: 866-723-2823 or Scan/e-mail: Synthes6734@stericycle.com Option 2: Call DePuy Synthes Repair Department at 1-800-288-6698 to order repair part. The replacement part will be sent directly to your facility. Questions should be directed to 610-719-5450 or a local DePuy Synthes sales consultant.

Root cause

Process control

Status

Terminated

Product code

FZX

Quantity affected

183

Distribution

Nationwide Distribution

Date initiated

2015-02-17

Date posted

2015-03-16

Date terminated

2016-08-26

Location

West Chester, PA