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
Sternum Saw Collet Nut - Product Code KFK
원인
The sternum saw collet nut that is used to insert and hold the saw blade in place may not always allow for the easy insertion of a saw blade into the handpiece for use. the nut needs to be in a certain position in order for the blade to be inserted and this may delay the operation of the device especially in emergency situations.
조치
Linvatec will send each consignee a recall package that will include: a 12/20/2005 recall letter and reply form, A product correction instruction sheet , a new Sternum Saw Collet Nut and an assembly manual. Linvatec will also contact each consignee by phone or email. All consignees that have not responded by 30 days after the first mailing will be re-contacted by the firm by mail, phone or email.
ConMed Linvatec Sternum Saw Collet Nut, Catalog Number 5059-09: Used on ConMed Linvatec Sternum Saw Handpieces (ConMed Linvatec, Hall. Versipower, Versipower Plus Handpieces) and sold individually.