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
Bone fixation appliances - Product Code HSB
원인
Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
조치
The firm sent Urgent Recall Notices to all direct accounts, hospital Risk Management and Physicians by first class mail.
Letters are dated March 29, 2009, April 2, 2009 and April 16, 2009 respectively. The letter describes the problem and that that there is a possible risk of a device failure.
An additional e-mail was sent on May 22, 2009 to 5 customers due to an expansion of the recall to include 4 additional items.
On June 19, 2009, the firm again expanded the recall to include 2 additional products and notified customers.
Questions should be directed to William Hennig, at 1.973.299.9300. ext. 1557.
Worldwide - US -NY, NJ, MI, MD, FL, GA, PR, MN, SD, OK, TX,, LA, CA, PA, OH, NV, HI, ME, NC, KS, UT, CO, TN, WV, VA, and WA. Foreign: Brazil, Colombia, Denmark, Germany, Finland, Greece, Italy, Japan, The Netherlands, Switzerland, Sweden, Portugal, Spain, United Kingdom, Saudi Arabia, and Trinidad.
제품 설명
Bone Screw 5.5MM X 55MM Bone Screw Lck-Cann, Rx only || Biomet, 100 Interpace Parkway, Parsippany, NJ 070454 || The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws.