Events

Recall of ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

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

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
    79147
  • Event Risk Class
    Class 2
  • Event Number
    Z-0810-2018
  • Event Initiated Date
    2017-09-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161444
  • 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
    When the lever of the insertion handle is in the "locked" position, the implant may be able to pivot rather than maintaining a rigid connection.
  • Action
    A recall letter, dated August 25, 2017, titled "Product Recall Re: AccuLIFTL Insertion Handle" instructing customers to meet with the Stryker Representative issuing the letter, complete the requested form and return any affected product to this representative. Questions or concerns can be directed to Customer Service at 201-749-8699

Device

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  • Model / Serial
    Model# 800804 Lot numbers 160010 and 170003
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationally
  • Product Description
    AccuLIF TL Insertion Handle || The AccuLIF Insertion Handle attaches to the implant and is specifically designed to allow a surgeon to insert the implant into the disc space with a fixed engagement between the two components to permit a controlled positioning of the implant in the anterior portion of the intervertebral space, and then through activation of the rotational pivot between the Handle and implant for final placement of the crescent-shaped cage across the anterior portion of the disc space. The AccuLIF TL Cages are indicated for intervertebral body fusion with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DOD) at one level or two contiguous levels from L2 to S1.
  • Manufacturer
    Howmedica Osteonics Corp.

Manufacturer

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