Events

Recall of Device Recall Aesculap PEEK Intervertebral Body Fusion System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Aesculap, 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
    65703
  • Event Risk Class
    Class 2
  • Event Number
    Z-1806-2013
  • Event Initiated Date
    2013-06-18
  • Event Date Posted
    2013-07-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119939
  • 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
    Intervertebral fusion device with bone graft, lumbar - Product Code MAX
  • Reason
    Aesculap implant systems, llc initiated a recall of the aesculap prospace peek 5 degree implant - 8 x 8.5 x 22 mm (sn038p) because the device is incorrectly etched with an 8 degree lordosis instead of a 5 degree lordosis. the device is labeled correctly, only the etching of the implant may be incorrect.
  • Action
    Aesculap notified customers via email and phone on June 18, 2013, and were instructed to check their inventory and return affected product to Aesculap. Aesculap believes that the risk to patient is low. For further questions please call 1-800-234-9179.

Device

Device Recall Aesculap PEEK Intervertebral Body Fusion System
  • Model / Serial
    Part no. SN038P, batch number 51915765
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution including the states of NV and MI
  • Product Description
    ProSpace Peek Implant 5 degree x 8.5 x 22 mm || The device is intended for vertebral body replacement or intervertebral body fusion to aid in the surgical correction or stabilization of the spine. The Aesculap PEEK Spinal Implant System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
  • Manufacturer
    Aesculap, Inc.

Manufacturer

Aesculap, Inc.
  • Manufacturer Address
    Aesculap, Inc., 3773 Corporate Pkwy, Center Valley PA 18034-8217
  • Manufacturer Parent Company (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA