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.
The surface finish inside of the broach is not to specification and the instrument may corrode if cleaned and sterilized according to instructions.
조치
Distributors were notified by an "Urgent: Device Recall" letter dated March 13, 2009. The letter described the affected product, reason for recall, health risks and actions for distributors and user facilities. Customers were instructed to quarantine affected instruments and return them to the Zimmer Product Service Department. Distributors were also instructed to provide the name and address of hospitals where the instruments were used so that a copy of the recall letter can be forwarded to the user facilities.
Direct questions about this recall to Zimmer, Inc. by calling 800-613-6131.
Worldwide Distribution -- US, Australia, and Germany.
제품 설명
Zimmer Nexgen Complete Knee Solution Fluted Stemmed Tibial Broach, Size 7, 8, nonsterile; REF 5997-61-07. || A reusable cutting instrument that is used in total knee arthroplasty surgery.