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
Rod, fixation, intramedullary and accessories - Product Code HSB
원인
The packaging contains the wrong product. it does not contain model hr-0824-s as the package indicates.
조치
Acumed sent an Urgent Notice Device Recall letter dated March 5, 2012, to all affected consignees. A follow-up notification letter was sent to the domestic customers on March 9, 2012. The letter identified the product, the problem, and the action to be taken by the consignee. The consignees were instructed to further notify their consignees about the recall and to cease use of and return the affected product. Consignees were requested to respond using the enclosed response form. The form should be faxed to 503-520-9618. For questions regarding this recall call 503-627-9957, ext. 1302.
Worldwide Distribution - USA (nationwide) and the countries of Italy, Ireland, and Great Britain.
제품 설명
The Polarus Plus Humeral Rod (part number HR-0824-S) is intended as an intramedullary fixation device for humeral fractures. It is sealed in an internal sterile blister pack within a box that is labeled in part: "Polarus Humeral Fixation System Size: 8mm X 240mm Polarus Plus Humeral Rod***Titanium***REF HR-0824-S***LOT 266220***RX only***Manufactured or distributed by: ACUMED 5885 NW Cornelius Pass Road Hillsboro, OR 97124 USA***"