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 is initiating a lot specific recall of the trabecular metal" reverse glenosphere distractor due to the potential of the device not functioning properly should it be utilized without proper lubrication. as a result, there is a potential for the device to fail to provide impact to the glenosphere when the trigger is pulled. in addition, there is a potential for the foot of the device to fract.
조치
Zimmer sent a Urgent Medical Device Recall Notification letter August 1, 2013, and via E-mail and courier to all affected customers. The initial recall notice identified the reason for the recall, possible adverse risks and injuries and informed customers that a replacement will be available in the coming months. In addition, this letter will remind that the instrument is to be lubricated before each use and to inspect the foot.
Customers are instructed to inspect any recalled product before and after use for cracks at the foot and ensure the foot is intact. Also ensure all moving parts are lubricated prior to each use according to the Recommendations for Care, Cleaning, Maintenance, and Sterilization Manual 97-5000-170-00. If you find a device which does not function properly or has a damaged foot, provide it to your Zimmer sales representative for return to Zimmer on a Product Experience Report (PER). Questions and concerns should be addressed to the Zimmer customer call center at 1-877-946-2761 between the hours of 8 a.m. and 5 p.m. EST.
Phase 2: As devices become available for distribution, a 2nd letter will be sent to the distributors and risk managers. Distributors will be instructed to order replacement devices as a means of completing the affected instrument cases in circulation within their territories. Instructions for the return of devices will be included.
Worldwide Distribution - USA (nationwide) including the countries of Singapore, Brazil, Taiwan, Australia, Canada, Germany(with further distribution to UAE, Austria, Belgium, Switzerland, Czech Republic, Denmark, Spain, Finland, France, Greece, Israel, Italy, Malta, Norway, Portugal, Sweden and South Africa,
제품 설명
00 4309-049-00 Trabecular Metal Reverse Shoulder Glenosphere Distractor Rx, Non sterile (sterilize before use) || The Glenosphere Distractor must be able to attach, connect, or mate with the Glenosphere and remove it without dislodging or loosening the base plate from the glenoid, or damaging the glenoid. Pulling the trigger releases a weight inside the Distractor. This force is transmitted to the bottom of the glenosphere dislodging it from the base plate.
“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.