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
Limb Lengthener - Product Code HSB
원인
Iskd lengthening device has the potential for not pre-distracting. this may cause or contribute to device malfunction, and if not discovered prior to use, may require surgical re-intervention or removal.
조치
Firm notified consignees by letter sent via certified mail on 10/9/2009. Follow up is planned for nonresponders. Questions are directed to the firm at (800) 527-0404.