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.
Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery.
조치
The firm issued the following notice on May 7, 2014: URGENT MEDICAL DEVICE RECALL NOTICE:
This notification is to inform you of an Urgent Medical Device Recall initiated by Biomet Orthopedics ("Biomet") which involves Part Numbers: 110003458 G7 Positioning Guide Rod and 110003500 G7 Positioning Guide Post. These instruments have been consigned and/or invoiced to your account. Biomet has initiated this action following an investigation which identified that positioning guide rod may fracture during impaction of the acetabula shell. If the positioning guide rod fractures, then the positioning guide post may become stuck to the insertion handle. There is no adverse health outcome expected for the patient.
This action requires the immediate location and discontinued use of the product and its return to Biomet.
The following actions are REQUIRED:
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.
If you have further distributed this product, you MUST notify hospital personnel of this action via the enclosed "Dear Risk/Recall Manager" notice. This letter MUST be given to hospital personnel responsible for receiving recall notices. However, you are charged with the location and return of these products.
“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.