“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.
Intramedullary (SP 2 IM) Rod 400mm Instrument (surgical instrument used in both primary and revision P.F.C. SIGMA knee procedures)PN 96-6120Dates manufactured:4 April 1995 - 22 June 2001 (Material 17-4-SS)27 August 2008 to 2 October 2012 (Material 455 SS)Kits containing SP2 IM Rod 400mm Instruments (PN 96-6120) include:ZZINAUK001 ZZINAUK0605 ZZINAUK9054 (WA ONLY)ZZINAUK9079 (WA ONLY)ZZINAUK9094 (WA ONLY)ARTG Number: 132151
Various surgical instruments actuated by the da Vinci Si Single Site Grip Release mechanismMultiple products affectedAll Lot Numbers AffectedARTG Numbers: 146826 and 132453
Torque Limiting Adapter for use in orthopaedic and trauma surgical procedures (Re-useable surgical instrument) Part Number: 00-2360-080-00All lot numbers affectedARTG Number: 260719
Triathlon Modular Handle(a reusable surgical instrument used in total and partial knee replacements)Item Number: 6541-4-808All Lot Numbers ARTG Number: 140892