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.
Recall initiated in response to a biomet canada report, which noted that while testing the instruments, the pin used to secure the implant on the device did not engage on the effected lots and were distributed.
조치
On 8/3/11 Biomet Orthopedics sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letter to all affected customers.
The letter included: reason for the recall, risks associated with use of the device, and alternate instructions for use of the recalled device. Customers are instructed to locate the affected products, discontinue use, return the devices, and a fax a copy of the response form.
For information or questions on this recall call Biomet at (574) 372-1570.
International Distribution Only: Canada, Australia, and Columbia.
제품 설명
Comprehensive Reverse Humeral Fracture Inserter || REF 406993 Comprehensive Instrumentation Reverse Humeral Inserter QTY 1. || Instrument that is attached to the trial prosthesis for placement in the prepared bone canal to check for correct sizing, version and humeral length. Also used to insert the humeral implant into the canal.
“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.