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.
It was reported that the surgeon noticed that the echo 11mm hip stem had an etching indicating it was 13mm stem.
조치
The firm, Biomet, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated November 8, 2012 to its customers. The notice describes the product, problem and actions to be taken. The customers were instructed to take the following actions:
¿ Immediately locate and remove the identified device(s) listed below from circulation.
¿ Carefully follow the instructions on the enclosed FAX Back Response Form .
¿ Fax a copy of the Response Form to 574-372-1683 prior to return of product.
¿ Use priority carrier for your shipment.
Questions related to notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
Nationwide distribution: USA including states of: AZ, MD, and KS.
제품 설명
Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous Stem (Orthopedic Implant) || Indications: 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2) rheumatoid arthritis, 3) correction offunctional deformity, 4) treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques, 5) revision of previously failed total arthoplasty.
“The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.