Events

Recall of Device Recall Medial biopsy plate

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by USA Instruments Incorporated.

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
    37263
  • Event Risk Class
    Class 2
  • Event Number
    Z-0516-2007
  • Event Initiated Date
    2007-01-31
  • Event Date Posted
    2007-02-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50213
  • 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
    biopsy plate - Product Code LNH
  • Reason
    The packaging used for the breast biopsy plate may exhibit small holes or tears.
  • Action
    The recalling firm notified consignees via certified letter, dated 1/31/07.

Device

Device Recall Medial biopsy plate
  • Model / Serial
    All lot codes
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Canada, Mexico, Argentina, Australia, Austria, Bhutan, Brazil, Chile, China, Denmark, Finland, Germany, Great Britain, Greece, Guatemala, Honduras, Hong Kong, Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Netherlands, New Zealand, Panama, Puerto Rico, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, and Turkey.
  • Product Description
    The recalled product is the medial biopsy plate, part #2414342. The biopsy plate is labeled in part: Medial Biopsy Plate, part 2414342, For Use with the Liberty 9000 8-Channel Breast Coil, USA Instruments, Inc., Aurora, OH, sterile. The breast biopsy plate is used with GE coils during Magnetic Resonance breast biopsy procedures. The medial biopsy plate, part #2414342 is packaged and sold as a part of catalogue numbers E8800BF, M3087JG, G3087JH, and M3335LA.
  • Manufacturer
    USA Instruments Incorporated

Manufacturer

USA Instruments Incorporated
  • Manufacturer Address
    USA Instruments Incorporated, 1515 Danner Dr, Aurora OH 44202-9273
  • Source
    USFDA