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
bone distractor - Product Code LXT
원인
Markings reversed: graduated markings on telescoping bone distractors were reversed, causing the distractors to compress rather than distract the treatment site when adjusted.
조치
Orthofix notified sales agents by phone starting on 09/28/07. Sales agents were to return product for replacements.
Lot numbers: For Catalog #50-1101 (75mm): 075; For Catalog #50-1014 (100mm): 7241, 076 and 50826; For Catalog #50-1015 (150mm): 2664-01, 7343 and 080; For Catalog #50-1016 (200mm): 145, 7342 and 068.