Events

Recall of Device Recall djo surgical6.5 mm cancellous bone screw

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Encore Medical, Lp.

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
    62561
  • Event Risk Class
    Class 2
  • Event Number
    Z-2146-2012
  • Event Initiated Date
    2012-07-16
  • Event Date Posted
    2012-08-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-12-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111018
  • 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
    One lot of the 010-55-030, 6.5 mm cancellous bone screw was recalled because a product complaint identified a mislabeling of the device. although the package label indicates size 30mm, the screw dimension is actually 25mm.
  • Action
    DJO Global sent an Urgent Field Safety Notice dated July 16, 2012, to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to forward the notice to all thoe who need to be aware within their organization or to any other organization where the potentially affected product was transferred, contact customers to place a replacement order and receive an RMA number, and return all affected devices using the RMA number. For questions customers should call 512-834-6255. For questions regarding this recall call 512-832-9500.

Device

Device Recall djo surgical6.5 mm cancellous bone screw
  • Model / Serial
    Lot 007A1037, Ref 010-55-25.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including AR, CA, FL, ID, OK, PA, TX, and UT.
  • Product Description
    djo surgical Screw 6.5 mm, Sz 25mm, low profile. || Product is intended for the fixation of the acetabular shell or fracture repair
  • Manufacturer
    Encore Medical, Lp

Manufacturer

Encore Medical, Lp
  • Manufacturer Address
    Encore Medical, Lp, 9800 Metric Blvd, Austin TX 78758
  • Source
    USFDA