Events

Recall of Device Recall ROC Lumbar bolt caddy

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Alphatec Spine, 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
    52760
  • Event Risk Class
    Class 2
  • Event Number
    Z-0036-2010
  • Event Initiated Date
    2008-12-16
  • Event Date Posted
    2009-10-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-11-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83899
  • 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
    Surgical Tray - Product Code LRP
  • Reason
    Alphatec discovered that the lot of bolt caddies had the incorrect bolt length laser etched on one side of the caddy. the actual roc bolts themselves are correctly laser etched.
  • Action
    Alphatec contacted consignees via phone on December 16, 2008 and informed consignees that they will arrange to have Federal Express contact them for pick-up. Consignees were asked to check their inventory to see where this product is located, and ensure that it is put on hold for return; and what days and hours they are in the office, (Confirm address: attach copy of the pick-up request form.) If they have any follow up questions, they were told to call 1-800-922-1356.

Device

Device Recall ROC Lumbar bolt caddy
  • Model / Serial
    Lot Number: 53298
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- Including states of TX, FL, & NJ.
  • Product Description
    ROC Lumbar bolt caddy, Part Number: 81997-01-05. || Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.
  • Manufacturer
    Alphatec Spine, Inc.

Manufacturer

Alphatec Spine, Inc.
  • Manufacturer Address
    Alphatec Spine, Inc., 5818 El Camino Real, Carlsbad CA 92008-8816
  • Manufacturer Parent Company (2017)
    Alphatec Holdings Inc.
  • Source
    USFDA