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
Multiple Component Metallic Bone Fixation Appliance - Product Code LXT
원인
Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.
조치
Distributors and consignees were notified by an Urgent: Device Recall letter dated 5/1/09. Consignees were advised to stop using the device and quarantine it immediately. Distributors were instructed to carry out a physical count of all affected product and record the data on the Inventory Return Certification Form; fax a copy of the completed form to Zimmer, Inc.; and return recalled product along with the Inventory Return Certification Form to the firm.
Worldwide Distribution -- USA, Australia, Canada, El Salvador, England, Germany, Latin America, and Singapore.
제품 설명
TransFx External Fixation System Drill Bit, Quick Connect, 3.5 mm diameter, 195 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-61. TransFx drill bits can be found in the following kits: TransFx Intermediate External Fixation System, REF 4450-05-10; TransFx Large External Fixation System, REF 4450-010-10 and TransFx Small External Fixation System, REF 4450-00050-15. || For use in pre-drilling bone to accept a fixation pin, which are part of the external fixation structure that the surgeon assembles intra-operatively to stabilize bone fractures from the extremities.