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.
The firm determined that the labeling (surgical technique) should be updated to clarify the proper technique and instrumentation to perform calcar planing to the bone, i.E., to include a caution statement about the potential for instrument breakage if bending or torsional forces are applied.
조치
Exactech sent an Field Advisory Notice dated May 22, 2017, by mail informing the customers the updated surgical technique is available on Exactech's website (www.exac.com). The notice requested consignees:
Extend the information to accounts in possession of the product
Complete & return the attached Field Advisory Notice Response Form to Exactech. For further questions, please call (800) 392-2832.
Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AL, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MN, NC, NJ, NV, NY, OH, OK, OR, RI, SC, TN, TX, VA, WA, WI, Hawaii., and to the countries of : Argentina, Australia, Austria, Brazil, China, Colombia, France, Germany, Guatemala, India, Italy, Japan, Spain, Switzerland, Turkey, and United Kingdom
제품 설명
Exactech 1.5" Novation Calcar Planer Guide Tip || To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use. || ech 1.5" Novation Calcar Planer Guide Tip