Events

Recall of Device Recall Medline Anterior Cervical Distraction Pin

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by MEDLINE 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
    76298
  • Event Risk Class
    Class 2
  • Event Number
    Z-2104-2017
  • Event Initiated Date
    2016-12-14
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152772
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Reason
    Product's non-conformity involves the integrity of the seal in the sterile packaging. it is possible that the seal on the sterile packaging has been compromised resulting in a loss of sterility of the medical device contained within.
  • Action
    Medline Industries sent an Immediate Action Required letter dated December 14, 2016, to all affected customers with response forms via US mail, notifying them of the recall. Customers were instructed to quarantine affected product and return it to the firm. The product will be repackaged and sterilized. Customers with questions were instructed to call 866-359-1704. For questions regarding this recall call 847-643-3245.

Device

Device Recall Medline Anterior Cervical Distraction Pin
  • Model / Serial
    16 mm Pin: Item# MDS9091212; Lots #136469, 136754 | 18 mm Pin: Item# MDS9091818; Lot #136470
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    16 mm [or 18 mm] Distraction Pin, Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA || Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures.
  • Manufacturer
    MEDLINE INDUSTRIES INC

Manufacturer

MEDLINE INDUSTRIES INC
  • Manufacturer Address
    MEDLINE INDUSTRIES INC, 3 Lakes Dr, Northfield IL 60093-2753
  • Manufacturer Parent Company (2017)
    Medline Industries Inc.
  • Source
    USFDA