Device Recall NEXGEN COMPLETE KNEE SOLUTION EXTRAMEDULLARY MODULAR SPIKE ARM POST
Modèle / numéro de série
REF 00-5901-074-00, Lots 61488062, 61549223, 61584526, 61593951, 61516298 and 61517186; and according to the firm's addendum dated 6/13/11,61634588 and 61625084.
Worldwide distribution: USA (nationwide) and countries including: Australia, Canada, Germany, Japan, New Delphi and Singapore. Addendum: Finland, Switzerland, UK, Denmark, Spain, Portugal, France, Netherlands, Italy, South Africa, Norway, Spain, and Sweden.
Description du dispositif
Posterior Referencing Instrumentation for the NEXGEN¿ COMPLETE KNEE SOLUTION EXTRAMEDULLARY MODULAR SPIKE ARM POST, REF 00-5901-074-00, NONSTERILE, Zimmer UK, Ltd.,, Zimmer Warsaw,IN || This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
“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.