Events

Recall of Device Recall AOS Trochanteric Nail

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Advanced Orthopaedic Solutions Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    54538
  • Event Risk Class
    Class 2
  • Event Number
    Z-1192-2010
  • Event Initiated Date
    2010-01-14
  • Event Date Posted
    2010-03-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88682
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    rod, fixation, intramedullary and accessories - Product Code HSB
  • Reason
    The recall was initiated after advanced orthopaedic solutions (aos) became aware of a manufacturing defect involving the short trochanteric nail, where one piece was found to be incorrectly bent. if this issue were to recur, surgery time could be extended, but only slightly as nail exchanges take place commonly in a surgery of this type.
  • Action
    The recall was initiated with the firm forwarding a recall notice with attached customer response form on January 14, 2010 to the affected consignees. The recall notice informed the consignees of the reason for recall and gave them three steps to follow to inspect the affected Short Trochanteric Nail products. Consignees were provided with product return instruction for any incorrectly bent products found during their inspection. Customers with questions are instructed to contact the firm at (310) 533-9966.

Device

Device Recall AOS Trochanteric Nail
  • Model / Serial
    Lot Numbers: 09024 & 09082.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide and Japan
  • Product Description
    AOS Trochanteric Nail, 12mm x 20cm x 135¿, Product Part Number: 1043-200.
  • Manufacturer
    Advanced Orthopaedic Solutions Inc

Manufacturer

Advanced Orthopaedic Solutions Inc