Device Recall Cross Drive Screw

  • Modèle / numéro de série
    Lot # 202450
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA including CA, GA, OH, TX, and VA and the countries of S Africa and Japan
  • Description du dispositif
    Package of center-drive bone screws labeled in part: "***REF: 01-7204***1.5MM" SYSTEM CENTER-DRIVE SCREW, 5/ PKG***1.5 X4MM TITANIUM***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.***BIOMET MICROFIXATION***1520 TRADEPORT DRIVE***JACKSONVILLE, FL 32218 USA***www.biometmicrofixation.com***" || "***REF: 99-7204***"1.5MM" SYSTEM CENTER-DRIVE SCREW, 1/ PKG***1.5 X4MM TITANIUM***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.***BIOMET MICROFIXATION***1520 TRADEPORT DRIVE***JACKSONVILLE, FL 32218 USA***www.biometmicrofixation.com***" || REF: 01-7204 1.5MM" SYSTEM CENTER-DRIVE SCREW, 5/ PKG, Lot 202450. || REF: 99-7204 "1.5MM" SYSTEM CENTER-DRIVE SCREW, 1/ PKG, Lot 202450. || Internal fixation screw intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Biomet Microfixation, Inc., 1520 Tradeport Dr, Jacksonville FL 32218-2480
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “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.
  • Source
    USFDA

Un dispositif médical avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Lot # 622120
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA including CA, GA, OH, TX, and VA and the countries of S Africa and Japan
  • Description du dispositif
    Package of cross-drive bone screws labeled in part: "***REF #95-1504***"1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/ PK***1.5 X4MM TITANIUM***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN***BIOMET MICROFIXATION***1520 TRADEPORT DRIVE***JACKSONVILLE, FL 32218 USA***www.biometmicrofixation.com***" || "***REF: 91-1504***"1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW***1.5 X4MM TITANIUM***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.***BIOMET MICROFIXATION***1520 TRADEPORT DRIVE***JACKSONVILLE, FL 32218 USA***www.biometmicrofixation.com***" || Products subject to recall: || REF #95-1504***"1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/ PK, Lot 622120. || REF: 91-1504***"1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 1/PK, Lot 622120. || Internal fixation screw intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system.
  • Manufacturer