Device Recall ATN System

  • Model / Serial
    903208000 903208010 903208015 903208020 903208025
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    USA (nationwide)
  • Product Description
    ACE Trochanteric Nail System || STER TROC END CAP || STER TROC END CAP 5MM || STER TROC END CAP 10MM || STER TROC END CAP 15MM || STER TROC END CAP 20MM || STER TROC END CAP 25MM || The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “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

10 devices with a similar name

Learn more about the data here

  • Model / Serial
    903011225 903011230 903011235 903013225 903013230 903013235
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    USA (nationwide)
  • Product Description
    ACE Trochanteric Nail System || ACE TROCH NAIL 125 DEG. X 11MM || ACE TROCH NAIL 130 DEG. X 11MM || ACE TROCH NAIL 135 DEG. X 11MM || ACE TROCH NAIL 125 DEG. X 13MM || ACE TROCH NAIL 130 DEG. X 13MM || ACE TROCH NAIL 135 DEG. X 13MM || The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.
  • Manufacturer
  • Model / Serial
    903209125 903209130 903209135
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    USA (nationwide)
  • Product Description
    ACE Trochanteric Nail System || STER TROC NAIL 125 DEG X 9MM || STER TROC NAIL 130 DEG X 9MM || STER TROC NAIL 135 DEG X 9MM || The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.
  • Manufacturer
  • Model / Serial
    903211070
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    USA (nationwide)
  • Product Description
    ACE Trochanteric Nail System || STER TROC LAG SCR 70 MM || The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.
  • Manufacturer
  • Model / Serial
    903211125 903211130 903211135
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    USA (nationwide)
  • Product Description
    ACE Trochanteric Nail System || TROCH NAIL ST 11X180 125DG STRL || TROCH NAIL ST 11X180 130DG STRL || TROCH NAIL ST 11X180 135DG STRL || The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.
  • Manufacturer
  • Model / Serial
    903211140 903211225 903211230 903211235
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    USA (nationwide)
  • Product Description
    ACE Trochanteric Nail System || STER TROC NAIL 180X11X140 || STER TROC NAIL 125 DEG X 11MM || STER TROC NAIL 130 DEG X 11MM || STER TROC NAIL 135 DEG X 11MM || The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.
  • Manufacturer
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