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 had received complaints that reported breakage of the persona knee trial articular surface provisionals (tasps). this is a retrospective recall which covers zimmer's corrective actions taken earlier this year concerning the tasps.
조치
On February 10, 2014, Zimmer sent letter to surgeons who had filed complaints regarding the affected TASP fractures. The letter provided the surgeons with Zimmer's investigational findings of the issue. Surgeons were directed to send questions or any additional informtion to Zimmer.PER@Zimmer.com. The Zimmer Weekly Wrap-Up, dated February 14, 2014, was issued electronically to sales force. They were notified to engage in mandatory training to improve the usage of the TASPs and prevent potential breakage. Zimmer has taken additional corrective measures by initiating another recall in July 2014 whereby they notify the distributors as well as all users of the enhanced surgical technique.
Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY, and the countries of Australia, Canada, Germany, India, Japan, Korea, and Singapore.
제품 설명
Persona (TM) The Personalized Knee System || Tibial Articular Surface Provisional Bottom || Nonsterile || PSN A/S PROV L CD BOTTOM +0MM || PSN A/S PROV L CD BOTTOM +6MM || PSN A/S PROV L EF BOTTOM +0MM || PSN A/S PROV L EF BOTTOM +6MM || PSN A/S PROV L GH BOTTOM +0MM || PSN A/S PROV L GH BOTTOM +6MM || PSN A/S PROV L J BOTTOM +0MM || PSN A/S PROV L J BOTTOM +6MM || PSN A/S PROV R CD BOTTOM +0MM || PSN A/S PROV R CD BOTTOM +6MM || PSN A/S PROV R EF BOTTOM +0MM || PSN A/S PROV R EF BOTTOM +6MM || PSN A/S PROV R GH BOTTOM +0MM || PSN A/S PROV R GH BOTTOM +6MM || PSN A/S PROV R J BOTTOM +0MM || PSN A/S PROV R J BOTTOM +6MM
“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.