Product was distributed Internationally to Argentina, Denmark, Norway, and UK. Product was distributed domestically to AL, CA, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MN, MO, MS, NC, OH, NY, PA, SC, TN, TX, UT, and VA.
Description du dispositif
BD Recalled component is labeled: || BD 60ml Syringe Luer-Lok Tip, REF 309653 STERILE. || BD Franklin Lakes, NJ 07417 USA Made in USA , www.bd.com. || Lots 7298534 Exp 2012-10 and 7334153 Exp 2012-11. || Component is found in: || TMJ SYSTEM ARTHROSIMPLICITY KIT REF 922070, STERILE PRODUCT, CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. || DISTRIBUTED BY: BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com || Kit contains individually packaged sterile products. || Kits are for lysis and lavage; the syringe is used for pumping saline into the joint.
“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.
Product was distributed Internationally to Argentina, Denmark, Norway, and UK. Product was distributed domestically to AL, CA, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MN, MO, MS, NC, OH, NY, PA, SC, TN, TX, UT, and VA.
Description du dispositif
BD Recalled component is labeled: || BD 60ml Syringe Luer-Lok Tip, REF 309653 STERILE. || BD Franklin Lakes, NJ 07417 USA Made in USA , www.bd.com. || Lots 7298534 Exp 2012-10 and 7334153 Exp 2012-11. || Component is found in: || TMJ SYSTEM ARTHROSIMPLICITY KIT - EU REF 922075, STERILE PRODUCT, CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. || DISTRIBUTED BY: BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com || Kit contains individually packaged sterile products. || Kits are for lysis and lavage; the syringe is used for pumping saline into the joint.