Events

Recall of Device Recall T2 Ankle Arthrodesis 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
    54249
  • Event Risk Class
    Class 2
  • Event Number
    Z-0845-2010
  • Event Initiated Date
    2009-12-29
  • Event Date Posted
    2010-02-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87957
  • 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
    Intramedullary Fixation Rod and Accessories - Product Code HSB
  • Reason
    Stryker orthopaedics became aware that there is the potential for damage to the sterile packaging of the product during transport.
  • Action
    Urgent Product Recall notification letters were sent to branches on 12/29, 2009, with a corrected version that included a list of catalog numbers and code numbers on January 11, 2009. Letters were also sent by Fed Ex on January 11, 2009 to Hospital Risk Management, Chief of Orthopaedics and surgeons who may have used the device. The letters identified the affected product, described the issue, and the hazards involved. The letter also asked customers to examine their inventory and hospital locations to identify the affected product. They are to retrieve all affected product and return it to their branch or agency warehouse for reconciliation. Customers are to reconcile all products utilizing the Product Recall Accountability Form. Questions should be directed to 201-972-2100.

Device

Device Recall T2 Ankle Arthrodesis Nail
  • Model / Serial
    lot codes: K125357, K158792, K185537, K199852, K227392, K452805, K455652, K461353, K624000, K732800, K769107, K782950, K785627, K820525, K858019, K863219, K868858, K893086, K951620, K963944, and  K983458.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution.
  • Product Description
    Stryker T2 Ankle Arthrodesis Nail, right; 011 x 300 mm; Catalog number: 18191130S; || Sterile, TI Alloy; || Stryker Trauma GmbH, Germany; || Distributed in the US by Howmedica Osteonics Corp, Mahwah, NJ. || Intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

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