Events

Recall of Torx 6.5mm Cancellous Bone Screw

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
    63358
  • Event Risk Class
    Class 2
  • Event Number
    Z-0388-2013
  • Event Initiated Date
    2012-08-17
  • Event Date Posted
    2012-11-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113569
  • 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
    Screw, fixation, bone - Product Code HWC
  • Reason
    Stryker has received reports from the field indicating that certain lots of 6.5mm cancellous bone screws are either associated with a product mix or potentially associated with a product mix. packaging associated with a 35 mm screw may contain a 25mm screw. conversely, packaging associated with a 25mm screw may contain a 35mm screw.
  • Action
    The firm, Stryker Orthopaedics, notified Domestic locations of this action by e-mail on August 6, 2012 and foreign locations of this action by e-mail on August 7, 2012. Stryker follow-up by sending an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" dated August 17, 2012 to their consignees/customers via Fed Ex with return receipt. The letter described the product, problem and actions to be taken. The customers were instructed to quarantine and return affected product to Attn: Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, New Jersey, 07430 (attach fluorescent orange sticker and mark box with words "Product Recall"), or contact your Stryker Sales Representative to arrange for return of the product ,and complete and return the attached Product Recall Acknowledgment Form within 5 days via fax to 855-251-3635. If you have any questions, feel free to contact the Manager, Divisional Regulatory Compliance at (201) 972-2100.

Device

Torx 6.5mm Cancellous Bone Screw
  • Model / Serial
    Catalog No: 2030-6535-1 Lot Code: MLDNAV, MLDXV2, MLH11M, MLH17R, MLH3K8, MLH4L6, MLH7RV, MLHK1X, MLHL99, MLJDJT Ref 2030-6535-1
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: USA (nationwide) and countries including: Canada, Belgium, Finland, Germany, Greece, Hong Kong, Ireland, Italy, Japan, Poland, Portugal, Spain, Turkey and UK.
  • Product Description
    Stryker Orthopaedics || Torx 6.5mm || Cancellous Bone Screw || Ref 2030-6535-1 || The 6.5mm Cancellous Bone Screws are used in THA when the surgeon elects to use a cluster/multi-hole shell in the acetabulum. The screws are intended to provide initial cup fixation and help prevent spin-out of the cup due to physical loading from the patient. They are intended as supplemental fixation.
  • 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