Worldwide distribution: USA (nationwide) including states of: AL, AR, CA, CO, CT, DC, CR FL,GA, HI, IA, IL, IN, KS, KY, LA, MA, MD,ME, MI MN, MO, MS, MT, NC, ND, NJ, NY, OH, O K, OR, PA, RI, SC, TN, TX, UT, VA and WA; and countries of: Argentina, Bahrain, Canada, Colombia, Costa Rica, and Finland.
Description du dispositif
"***REF: 922090 TMJ SYSTEM InnerVue SCOPE PROCEDURE KIT***STERILE PRODUCT***STERILE EO***KIT CONTAINS BOTH STERILE AND NON-STERILE COMPONENTS DISTRIBUTED BY: BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***" || KIT WAS DISCONTINUED. || Kit Contains: Drape with pouch; 22g1.5in needle; OR towel; Towel clips; Skin market with rule; Band-aids; Syringe pump tubing set; Cotton ball; 60ml syringe; Facial ice pack; Extension tubing; Choloraprep Swabsticks; Shelf drape. || All-inclusive kit that alleviates the burden of piecing together each of the items necessary for a Arthroscopy using the OnPoint Scope.
“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 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.
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.
Worldwide distribution: USA (nationwide) including states of: AL, AR, CA, CO, CT, DC, CR FL,GA, HI, IA, IL, IN, KS, KY, LA, MA, MD,ME, MI MN, MO, MS, MT, NC, ND, NJ, NY, OH, O K, OR, PA, RI, SC, TN, TX, UT, VA and WA; and countries of: Argentina, Bahrain, Canada, Colombia, Costa Rica, and Finland.
Description du dispositif
"***REF: 922070 TMJ SYSTEM ARTHROSIMPLICITY KIT***STERILE PRODUCT***STERILE EO***DISTRIBUTED BY BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***" || THIS KIT WAS DISCONTINUED. || Kit Contained: Drape with pouch; 18Gx1.5in needle; OR towel; Towel clips; Skin marker with ruler; Band-aids; Cotton ball; 5ml syringe; 60ml syringe; Gauze sponges; Extension tubing; Chloraprep swabsticks; Utility Bowl. || All-inclusive kit that alleviates the burden of piecing together each of the items necessary for a TMJ arthrocentesis procedure.
Worldwide distribution: USA (nationwide) including states of: AL, AR, CA, CO, CT, DC, CR FL,GA, HI, IA, IL, IN, KS, KY, LA, MA, MD,ME, MI MN, MO, MS, MT, NC, ND, NJ, NY, OH, O K, OR, PA, RI, SC, TN, TX, UT, VA and WA; and countries of: Argentina, Bahrain, Canada, Colombia, Costa Rica, and Finland.
Description du dispositif
"***REF: 24-4050 TMJ SYSTEM ArthroSimplicity KIT***STERILE PRODUCT***STERILE EO***KIT CONTAINS BOTH STERILE AND NON-STERILE COMPONENTS DISTRIBUTED BY: BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***" || Kit Contains: Drape with pouch; 18Gx1.5in needle; OR towel; Towel clips; Skin marker with ruler; Band-aids; Cotton ball; 5ml syringe; Gauze sponges; Extension tubing; Cholarprep swabsticks; Utility Bowl. || All-inclusive kit that alleviates the burden of piecing together each of the items necessary for a Arthroscopy using the OnPoint Scope.