Events

Recall of Device Recall ASpace SIBD and Arcadius XP L systems

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
    72646
  • Event Risk Class
    Class 2
  • Event Number
    Z-0423-2016
  • Event Initiated Date
    2015-11-10
  • Event Date Posted
    2015-12-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-09-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142313
  • 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
    Screwdriver, surgical - Product Code LRZ
  • Reason
    The flexible shaft of the instruments may break during orthopedic spinal surgery. there is a risk of a delay in surgery or that a fragment from the shaft could be left in a patient.
  • Action
    The firm, Aesculap Implant Systems, sent a "URGENT MEDICAL DEVICE RECALL" letter dated Nov. 23, 2015 to all consignees via certified letter with return receipt. Distributors and sales reps will be notified via e-mail with return receipt. The letter described the product, problem and actions to be taken. The consignees were instructed to review the product recall notification in its entirety and ensure all users your organization and other concerned persons are informed; determine your current inventory; do not destroy any affected product; immediately remove and return the affected instruments-these instruments may be located within Set ST0485; use the U joint screwdriver, ME014R in place of the SJ706R of which is already part of set ST0485; If you require Customer Service assistance please call: Customer Service: 866-229-3002 or Email: SetWorld_Orders.BBMUS_Service@aesculap.com., and complete and return the Product Removal Acknowledgement Form to Aesculap Quality Assurance Department via mail to: Aesculap Inc., 615 Lambert Pointe Drive, Hazelwood, MO 63042; fax to: 610-791-6882 or email to: val.strawn@aesculap.com within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). A replacement for the SJ607R will be sent to you when one becomes available (ME190R). If you have any questions, contact via email: val.strawn@aesculap.com/Tel: 610-984-9414 or email: Gordon.young@aesculap.com/Tel: 610-984-9043.

Device

Device Recall ASpace SIBD and Arcadius XP L systems
  • Model / Serial
    all lots
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and country of: Canada.
  • Product Description
    Flexible Bone Awl; || SJ607R; NON STERILE; || B Braun Aesculap; || Aesculap AG: || These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.
  • 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