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
Nail, fixation, bone - Product Code JDS
원인
A specific part and lot number was packaged and shipped prior to the completion of a required internal inspection.
조치
The firm, Depuy Synthes, sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" notification letter, dated June 3, 2015, to direct accounts/customers. The letter described the product, problem and actions to be taken. The customers were instructed to review your inventory and immediately remove the affected lots from your stock; If you DO have any of the identified devices, please take the following steps:
¿¿ Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA)Complete and Return the Verification Section with the product to:
¿¿ Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132.
¿¿ Send a copy of the completed Verification Section even if you do not have any product to DePuy Synthes by:
¿¿ Fax: (610) 430-7083 or ¿¿ Scan/email: Fieldaction@synthes.com Number.
If you have any questions, please call 610-719-5450 or contact your DePuy Synthes Sales Consultant.
TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre-and post-isthmic fractures; and tibial malunions and non-unions.