Events

Recall of Allocraft TLIF Bone Inserter.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker 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
    31984
  • Event Risk Class
    Class 2
  • Event Number
    Z-0011-06
  • Event Initiated Date
    2005-04-04
  • Event Date Posted
    2005-10-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-08-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38862
  • 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
    Stryker was made aware that the short arm of the bone inserter may fracture during use and potentially result in an adverse health consequence.
  • Action
    The firm sent notification letters to their branches/agencies on 4/4/2005. 100% effectiveness to be achieved by completing Product Accountability forms, follow up telephone calls, and follow-up letters as required.

Device

Allocraft TLIF Bone Inserter.
  • Model / Serial
    Catalog No. 483600100; Lot Code: 04C570
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The product was distributed to the firm''s branches/Agencies that distribute the product to hospitals, etc. There are 8 locations.
  • Product Description
    Allocraft TLIF Bone Inserter.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2002
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA