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.
데이터 추가 비고
Fastener, fixation, nondegradable, soft tissue - Product Code MBI
원인
Investigation identified that the design of the drill bit may make the suture anchor difficult to insert into the bone. the implant may skip across the hole or miss the hole during insertion.
조치
Biomet sent an Urgent Medical Device Recall Notice letter dated October 10, 2013 to all consignees. The letter identified the affected product, reason for recall, and actions to be taken. The letter stated customers will be contacted on an individual basis in an attempt to reconcile the affected product. Customers were directed to locate and remove implicated devices and fax a copy of the response form to 574-372-1683 prior to returning product. For questions call 574-372-1570.
USA Nationwide Distribution in the states of VA, CA, Ky, and IN
제품 설명
Juggerknotless Drill Bit, REF 110003173, || Sterile, Single Use || Product Usage: || The Juggerknotless Soft Anchors are indicated for soft tissue reattachment procedures in the shoulder, foot/ankle, hand/wrist, and hip.
“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.