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
Stereotaxic instrument - Product Code HAW
원인
Inadequate weld on tracker, knob oversized and poor thread design on attachment screw results in seizing.
the instrument may break during use, resulting in surgical delay and an increased risk of infection.
조치
Firm's sales representatives were notified via e-mail on 8/6/07 to review their inventory and that of their accounts and to notify the firm of their location so that they could be replaced. Contact the firm by telephone at 574-267-6131 for additional information concerning this recall.