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
Hip Joint Femoral (hemi-hip) Metal/Polymer Cemented or Uncemented Prosthesis - Product Code KWY
원인
The apex hip system bipolar head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
조치
Omni Life Science notified distributors and implanting surgeons by an Urgent, APEX Hip System Bipolar Head Voluntary Recall letter dated June 29, 2009. The method of notification is both e-mail and FedEx overnight. The letter requires a signature acknowledging receiving the letter and the letter is to be faxed back to Omni Life Science. The Distributors/Sale Representatives are instructed to fill in the "Quantity Returned" on the recall letter and fax back to Omni. They are to ship all existing Apex Hip System Bipolar Head inventory by 07/10/2009 to the directed address.
Nationwide Distribution -- Including states of AZ, CA, CO, FL, IL, MI, NJ, OK, UT, VA, and WI.
제품 설명
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 59 mm OD || Product Code: H3-82859. || Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the hip.