Events

Recall of Long Length Dyax Nail.

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
    31986
  • Event Risk Class
    Class 2
  • Event Number
    Z-0256-06
  • Event Initiated Date
    2004-09-07
  • Event Date Posted
    2005-12-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-10-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38874
  • 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
    Nail, Fixation, Bone, Metallic - Product Code NDH
  • Reason
    Stryker became aware that catalog number 1594-1130s, lot code k559623 was manufactured with a lag screw hold angulation of 135 degrees rather than 130 degrees.
  • Action
    The firm sent out notification letters via FedEx on 9/7/2004 with return receipt.

Device

Long Length Dyax Nail.
  • Model / Serial
    Catalog No. 1594-4430S Lot K559623
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    The devices were distributed to Stryker branches and agencies. These are Stryker sales representatives located nationwide.
  • Product Description
    Long Length Dyax Nail.
  • 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