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 received two complaints of the tabs on the torque limiting t-handle fracturing during surgery. the firm performed internal testing and found that the tabs may fracture when used in the "off" or "locked" setting for hand-reaming the femoral canal.
조치
Biomet, Inc. made telephone calls to distributor accounts on January 28, 2011, with specific instructions that the Arcos Torque Limiting T-Handle was not to be used in the "OFF" position. Distributors were required to use the Arcos Torque Limiting T-Handle on the "55" setting for insertion of locking screws and troch bolt.
Biomet, Inc. sent an URGENT MEDICAL DEVICE RECALL NOTICE letter dated February 21, 2011, to their distributors. The letter stated that the firm was currently manufacturing replacement handles which would be distributed to the field shortly.
Consignees were advised to immediately discontinue use of the T-Handle in the "OFF" position.
Send back the current T-Handle as soon as they receive a replacement.
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 shipment.
If the product has been further distributed, consignees must notify hospital personnel of this action, via the enclosed "Dear Bioment Customer" notice.
This letter must be give to hospital personnel responsible for receiving recall notices. Consignees are charged with the location and return of these products.
Consignees were instructed to confirm receipt of this notice by calling, 800-348-9500, ext. 3755 or 3983.
For any questions call 574-371-3755 or 574-372-3983.
Worldwide Distribution - USA including the states of CA, NY, FL, VA, UT, IL, MI, KY, OH, MA, PA, SD, MO, TX, NV, Puerto Rico, and the countries of Australia, New Zealand, Canada.
제품 설명
ARCOS Modular Revision System Torque Limiting T-Handle 55 inch- pounds, REF 31-301850, Biomet Orthopedics Warsaw, IN. || The torque limiting T-handle is used with attachments and hex drivers for preparation of the femur and for locking screw insertion at specified torque limit in Arcos hip procedures.
“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.