Events

Recall of OPUS Minimagnum Implant Part Number OM2500

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Innovatech Medical Resources L.P..

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
    60049
  • Event Risk Class
    Class 2
  • Event Number
    Z-0628-2012
  • Event Initiated Date
    2011-08-08
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104346
  • 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
    Screw, fixation, bone - Product Code HWC
  • Reason
    Product is being removed from the field due to an over-label issue.
  • Action
    Innovatech Medical Resources L.P. decided to recall all products resterilized and overlabeled at their facility. A firm representative would visit each customer and request that they remove the overlabeled product from their shelves and secure it. Customers could call the MSI office to get a RMA (Return Materials Authorization) for a refund on this product. For questions regarding this recall call 817-714-9066.

Device

OPUS Minimagnum Implant Part Number OM2500
  • Model / Serial
    Lot Numbers 110730, 110874, 110400, 119256 and 117489
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including Texas
  • Product Description
    OPUS Minimagnum Implant Part Number OM-2500 is a bone anchor || Intended for rotator cuff repair
  • Manufacturer
    Innovatech Medical Resources L.P.

Manufacturer

Innovatech Medical Resources L.P.
  • Manufacturer Address
    Innovatech Medical Resources L.P., 5455 Honeysuckle Road, Midlothian TX 76065
  • Source
    USFDA