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.
데이터 추가 비고
Rod, fixation, intramedullary and accessories - Product Code HSB
원인
Tfna nails from certain lots were assembled with a locking mechanism too close to the top of the nail.
potential patient impact: surgical delay.
조치
An urgent Field Safety Notification, dated April 9, 2015, was sent to end users and sales consultants to alert them about the issue and request that they take the following actions: 1) review the instructions listed in this notification; 2)
forward this notice to anyone in your facility that needs to be informed; and 3) complete the attached Verification Section (page 4 of this notification) and send a copy of the completed Verification Section by: Fax: (888) 446-5160 or
Scan/email: Synthes3152@stericycle.com.