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.
Zimmer, inc. has determined that there is a potential for a package to be labeled as a 28 mm femoral
head but contain a 32 mm femoral head. in addition, there is a potential for the patient record label to
be incorrect.
조치
The firm, Zimmer, Inc., sent an "URGENT: DEVICE REMOVAL" letter dated July 9, 2010, to all consignees. The letter described the issue, clinical implications, affected product, and required actions. The consignees were instructed to carefully review the letter, ensure users of the VerSys Hip System Femoral Head device at their faculty have been informed of this removal and perform a physical count of all affected product at their facility, record the data on the Inventory Return Certification Form and/or the User Facility/HCP Form and return the form via fax at (574) 372-4265 or email: aimee.wood@zimmer.com. Zimmer Inc. will conduct a removal of all remaining (unused) units of the subject lots.
For shipping assistance, questions or assistance in notifying your accounts about the device removal, please contact Zimmer, Inc. at 1-800-613-6131 or 574-372-4463.
Worldwide distribution: USA and countries including Bolivia, Canada, New Zealand, Taiwan, Thailand, Singapore, and India.
제품 설명
VERSYS¿ HIP SYSTEM || FEMORAL HEAD 12/14 TAPER 28 MM DIA. -3.5 MM NECK LENGTH || ZIMALOY¿ CO-CR-MO ALLOY STERILE QTY-1 || MANUFACTURED BY ZIMMER MANUFACTURING B.V., || A SUBSIDIARY OF ZIMMER, INC. (WARSAW, IN) || The VerSys¿ Hip System Femoral Heads are intended for use in total hip arthroplasty and are assembled onto the proximal taper of the hip stem. The femoral heads manufactured from Zimaloy Alloy are intended for mating with Tivanium" Ti-6AL-4V Alloy and Zimaloy Alloy femoral stems equipped with taper necks. These femoral heads are available in two Morse-type taper options, 6-degree and 12/14, each of which mates with the corresponding 6 degree or 12/14 taper of a femoral stem prosthesis. Each taper option is supplied in a variety of diameters and neck lengths for use in total hip arthroplasty.
“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.