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
Toe Polymer Constrained Prosthesis - Product Code KWH
원인
Tornier, inc. has received a report of a mislabeled product due to a product mix-up. the package label indicated that the product was a model lmp-50 however the product inside the package was tornier fgt-50 implant (primus flexible great toe implant with grommetts).
조치
Consignees were sent on April 6, 2009 a Tornier "Urgent-Product Recall" letter dated April 3, 2009. The letter was addressed to Healthcare professionals and distributors. The letter described the problem and product involved. Advised consignees to immediately discontinue use of the affected product and to return any unused affected product to their facility. Advised their distributors to notify all accounts. They also attached a questionnaire needed for inventory status.