Events

Recall of Device Recall OSTEOMED PrimaLOK FF Threaded Implant Driver Shaft

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Osteomed, 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
    59213
  • Event Risk Class
    Class 2
  • Event Number
    Z-0008-2012
  • Event Initiated Date
    2011-06-07
  • Event Date Posted
    2011-10-04
  • 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=101895
  • 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
    System, facet screw spinal device - Product Code MRW
  • Reason
    Two of the implant driver assembly tips were reported to break during surgery.
  • Action
    OsteoMed LP sent an Urgent --Product Recall letter dated June 7, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory immediately for affected inventory and promptly return any affected inventory to: OsteoMed LP Attan: Rebecca Ellis 3885 Arapaho Road Addison, Texas 75001 If the customer further distributed any of the affected product customers were instructed to immediately contact their accounts and advise them of the recall situation and have them return any devices they may have to OsteoMed at the above address. Customers were asked to complete and return the enclosed response immediately in the enclosed, postage paid envelope even if they do not have the device. For any questions please call (800) 456-7779.

Device

Device Recall OSTEOMED PrimaLOK FF Threaded Implant Driver Shaft
  • Model / Serial
    Part Number 800-1212 lot # 1038452.
  • Product Classification
    Orthopedic Devices
  • Device Class
    Unclassified
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including PA, TX, CA, IL IA, FL, CT, and MO
  • Product Description
    OSTEOMED SPINE Facet Fixation System PrimaLOK FF Threaded Implant Driver Shaft OsteoMed L.P. 3885 Arapaho Road, Addison, Texas 75001
  • Manufacturer
    Osteomed, Lp

Manufacturer

Osteomed, Lp
  • Manufacturer Address
    Osteomed, Lp, 3885 Arapaho Rd, Addison TX 75001
  • Manufacturer Parent Company (2017)
    Colson Associates Inc.
  • Source
    USFDA