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
Extractor - Product Code HWB
원인
There is a potential for the connection screw of the stem extractor to break.
조치
The firm, DePuy Synthes, sent an "URGENT FIELD SAFETY NOTICE" dated 3/19/2018 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to the following:
¿ Review the instructions listed in this notification.
¿ Forward this notice to anyone in your facility that needs to be informed.
¿ If any of the affected product has been forwarded to another facility, contact that facility.
¿ Keep a copy of this notice.
¿ Return the Verification Section (page 3 of this letter) to Synthes by:
o Fax: 1-888-731-7954 or
o Scan/email: Synthes3091@stericycle.com
. Follow the Instructions if connecting screw for the stem extractor breaks
If you have any questions, please call 610-719-5450 or contact your DePuy Synthes Sales Consultant.