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
Cervical Spacer - Product Code MQV
원인
Unapproved testing: tissue supplier (lifelink) utilized unapproved diagnostic testing on certain lots of distributed donor tissue instead of the fda approved donor screening test. (note: tissue samples were later re-tested by an approved method and found non-reactive).
조치
Urgent Recall Notice letters were mailed on October 23, 2007, requesting location of all product including sub-accounts and return for credit.
Nationwide to distributors/customers in NY, NC, MO, CA, FL and KS
제품 설명
OsteoStim Cervical Allograft (Lordotic Cervical Spacer) || H. 7mm; W. 14mm; L. 10mm., Catalog Number: 45-5537 and Catalog Number : LGAL906, Distributed by EBI. (dba Biomet Spine, Biomet Trauma, Biomet Bracing, Biomet Osteobiologics) Parsippany, New Jersey 07054