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
Bit, drill - Product Code HTW
원인
Exactech inc. of gainesville, fl is recalling their novation modular drill bits after the devices were reported to have been used by end user while in a non-sterile condition.
조치
The firm, Exactech, Inc., called the lone customer on January 24, 2012 to discuss the product, problem and actions to be taken. The customer was instructed to return all unused devices and associated packaging.
Nationwide distribution: USA state of: Arkansas only
제품 설명
REF 101-45-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 4.5mm***Use with 20mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. || To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.