U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
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Guide, surgical, instrument - Product Code FZX
원인
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.
조치
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.
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.