FDA Recall Terminated

Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part number 03.010.048) and the Thumb Screw for the Aiming Arm for Titanium Cannulated Tibial Nails-EX (part number 03.010.052). The Recon Locking Aiming Arm for Lateral Entry Femoral Recon Nails- EX is used when locking the Femoral Nail-EX. The Aiming Arm for Titanium (TI) Cannulated Tibial Nails-EX is used when locking the Tibial Nail-EX.

Recall: Z-1281-2015 · Initiated February 17, 2015

Recall

Recall Number: Z-1281-2015
Event Number: 70455
Firm: Synthes, Inc.
FEI Number: 3005180112
Product Code: FZX
Status: Terminated
Root Cause: Process control
Initiated: February 17, 2015
Posted: March 16, 2015
Terminated: August 26, 2016
Address: 1302 Wrights Ln E, West Chester, PA, 19380-3417

Description

Reason

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

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: [email protected] 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.

Distribution

Nationwide Distribution

Quantity

183