Events

Recall of Device Recall Total Hip Tracecart

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by DeRoyal Industries 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
    54113
  • Event Risk Class
    Class 2
  • Event Number
    Z-1072-2010
  • Event Initiated Date
    2009-12-09
  • Event Date Posted
    2010-03-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-05-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87516
  • 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
    custom surgical kit - Product Code LRO
  • Reason
    Custom surgical kits contain stryker cbcii blood conservation kit which may lack sterility.
  • Action
    DeRoyal initiated its recall by visit on 12/09/2009 and followed by letter dated 12/18/2009

Device

Device Recall Total Hip Tracecart
  • Model / Serial
    Lot numbers: 08150012, 08156012, 08179012, 08172012, 08221012, 08207012, 08247012, 08249012, 08302012, 08270012, 08310012, 08312012, 08354012, 09022012, and 08354012
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    LA & MS
  • Product Description
    DeRoyal TOTAL HIP TRACECART, REF 53-1820.14, Rx ONLY, NON-STERILE. Custom surgical kit containing Stryker CBCII Blood Conservation Kit.
  • Manufacturer
    DeRoyal Industries Inc

Manufacturer

DeRoyal Industries Inc
  • Manufacturer Address
    DeRoyal Industries Inc, 200 Debusk Ln, Powell TN 37849-4703
  • Manufacturer Parent Company (2017)
    Deroyal Industries Inc.
  • Source
    USFDA