Events

Recall of Device Recall Apelo Modular Screwdriver for Apelo Pedicle Screw System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Atlas 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
    62564
  • Event Risk Class
    Class 2
  • Event Number
    Z-2274-2012
  • Event Initiated Date
    2009-06-04
  • Event Date Posted
    2012-08-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-07-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111339
  • 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
    Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
  • Reason
    Atlas spine, inc. recalled their apelo modular screwdriver, a component of the apelo pedicle screw system instrumentation, because of complaints received about the tip breaking. if the tip is fractured inside of the modular screw, the tip could become implanted in the body or if the entire screw is removed, it could cause a delay in the surgery.
  • Action
    Consignees were notified by Telephone and visit. All products will be returned, quarantined and then destroyed.

Device

Device Recall Apelo Modular Screwdriver for Apelo Pedicle Screw System
  • Model / Serial
    PN# 70175-001 CAT#2006-41-0000 Lot # 00686
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    USA Distribution to the state of Florida only.
  • Product Description
    Apelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEM***Modular Screwdriver***Atlas Spine, Inc.***www.AtlasSpine.com*** 1555 Jupiter Park Drive #4***Jupiter, Florida 33458***561-741-1108***Tissue Sleeve***MFG Date: XX/XX/XXXX***Lot #: XXXX***Weldment***MFG Date: 03/23/2009***Sleeve Assembly***MFG Date: XX/XX/XXXX***Lot #: XXXX***Qty: 1 Rx Only***Non-Sterile. Sterilize Prior to Use*** Rev. A***. The Modular Screwdriver is used to insert modular pedicle screw implants which are part of the Apelo System.
  • Manufacturer
    Atlas Spine, Inc.

Manufacturer

Atlas Spine, Inc.
  • Manufacturer Address
    Atlas Spine, Inc., 1555 Jupiter Park Dr Ste 4, Jupiter FL 33458-8085
  • Manufacturer Parent Company (2017)
    Atlas Spine Inc.
  • Source
    USFDA