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
Knee Prosthesis - Product Code NJL
원인
The implant surface may not have been polished adequately, which could result in increased wear and polyethylene debris generation.
조치
Consignees were notified by phone beginning on 4/17/09 and email and letter notifications were sent on 4/22/09. A dear surgeon letter entitled Urgent: Medical Device Recall, dated April 28, 2009, is being sent to implanting surgeons recommending patient monitoring. Consignees are to return the response form indicating their receipt of the notification. Questions or concerns should be directed to (800) 846-4637 or www.zimmer.com.
Worldwide Distribution -- USA including states of Arizona, California, Colorado, Hawaii, Illinois, Indiana, Michigan, Minnesota, Mississippi, New Jersey, New Mexico, New York, Ohio, Oregon, and Pennsylvania and country of Canada.