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    COLLARLESS POLISHED TAPER HIP PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CPT Hip System, Parts 00-8114-002-10 and 00-8011-004-00 Hip joint metal/polymer semi-constrained cemented prosthesis. The CPT Hip System is indicated for cemented use in: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis. Patients suffering from disability due to previous fusion. Patients with previously failed endoprostheses and/or total hip components in the affected extremity. Patients with acute femoral neck fractures. 510(k) K960658

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·January 8, 2014

    CPT Hip System, Parts 00-8114-002-10 and 00-8011-004-00 Hip joint metal/polymer semi-constrained cemented prosthesis. The CPT Hip System is indicated for cemented use in: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis. Patients suffering from disability due to previous fusion. Patients with previously failed endoprostheses and/or total hip components in the affected extremity. Patients with acute femoral neck fractures. 510(k) K960658

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code JDI·December 10, 2013

    DETARTRINE P

    FDA 510(k)
    FDA Class 1 ·Dental

    BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE, BLACK COLOR)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ARTERIAL CATH SET: 20GA X 5CM

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code DQY·June 20, 2014

    LANX SPINAL FIXATION SYSTEM

    FDA Adverse Event
    Other ·LANX, INC.·Product code MNI·February 12, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·January 13, 2011

    MONOCRYL UD 27IN USP2-0

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code GAN·October 25, 2024

    MONOCRYL UD 27IN USP2-0

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code GAN·October 25, 2024