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
Thoracolumbosacral pedicle screw system - Product Code NKB
원인
The plastic core of the decorticating planer was found to be missing, which could result in scoring of the bone screw neck if used at or beyond a 23 degree angle.
조치
Orthofix sent an Urgent Medical Device Product Recall letter dated August 2, 2017, to all affected customers. The letter explained the issue and requested return of product in their possession. Customers with questions were instructed to contact their local Orthofix representative. For questions regarding this recall call 214-937-2100.
Distribution was made to distributors located in CA, FL, and RI. There was no foreign/military/government distribution.
제품 설명
Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, non-sterile, Rx. || .A Decorticating Planer is used to decorticate bone surrounding the spherical head of an implanted bone screw in order to provide clearance to allow for proper seating of the modular body, as well as to provide full range of modular body angulation. It is placed axially over the spherical head of the bone screw and rotated clockwise and counterclockwise to achieve the needed decortication