Events

Recall of Device Recall Stryker Spine

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Spine.

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
    63272
  • Event Risk Class
    Class 2
  • Event Number
    Z-0163-2013
  • Event Initiated Date
    2012-07-05
  • Event Date Posted
    2012-10-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-01-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113355
  • 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
    Aviator drill bits are 10 mm longer than the reflex hybrid drill bits and are not interchangeable which could lead to over-drilling by as much as 10 mm.
  • Action
    Stryker Spine sent an Urgent Medical Device Field Correction Notification letter beginning July 5, 2012, to all affected customers. Teh letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check the drill bit length in each respective drill guide prior to surgery to ensure the correct length protrudes through the guide. Customers with questions should call 201-760-8298. Customers were asked to report any adverse events or product quality problems to 1-888-457-7463.

Device

Device Recall Stryker Spine
  • Model / Serial
    E207315 Catalog number 48770610, 48770612, 48770616 All lots
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide distribution.
  • Product Description
    Aviator Drill Bit (10 mm, 12 mm, 14 mm, 16 mm, || Manufactured by: Stryker Spine SAS Z.1 Marticot -33610- Cestas France || +33 (0) 5.57.97.06.30 || http://www.stryker.com || Distributed in the USA by Stryker Spine || 2 Pearl Ct., Allendale NJ 07401-1677 USA || +1-201-750-8000 || Drill bits are reusable instruments, sterilized prior to use, used in conjunction with an Aviator Drill Guide to provide a pathway for screw insertion. The aviator Anterior Cervical Plating (ACP) System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation.
  • Manufacturer
    Stryker Spine

Manufacturer

Stryker Spine
  • Manufacturer Address
    Stryker Spine, 2 Pearl Ct, Allendale NJ 07401-1611
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA