Events

Recall of Restoration Modular Cone Bodies

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
    51868
  • Event Risk Class
    Class 2
  • Event Number
    Z-1642-2009
  • Event Initiated Date
    2009-04-02
  • Event Date Posted
    2009-05-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81477
  • 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
    Femoral Hip Prosthesis - Product Code LZO
  • Reason
    Packaging burst test values for the restoration modular cone body family were found to be incorrectly transferred from the finalized validation to the work specification. testing showed that burst test results for recalled products fell below the validated parameters.
  • Action
    Urgent Product Recall letters were sent via Federal Express on April 2, 2009 to Stryker branches, Chief of Orthopaedics, Hospital Rick Management and Surgeons. The letter stated the issue, the potential hazards, and the risk mitigation. Customers were asked to examine their inventory and hospital locations to identify the affected products; retrieve all effected products and return it to their branch or agency warehouse for reconciliation; reconcile all products on the attached Product Accountability Form and fax a copy to the number listed; return the affected product via the Inter-Org Transfer and ship it to the attention of the individual listed; attach the fluorescent orange PRODUCT REMEDIATION sticker to their return, indicating the Product Remediation #, and mark the box with the words "PRODUCT RECALL". Questions should be directed to Colleen O'Meara at 201-831-5970.

Device

Restoration Modular Cone Bodies
  • Model / Serial
    Lot # 211080002; Lot # 22109602; Lot # 21883201; Lot # 21910302 and 21883401.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    Restoration Modular Cone Bodies; titanium Alloy and Hydroxyapatite, Sterile. Catalog number 6276-1-021, Catalog number 6276-1-025, Catalog number 6276-1-219, and Catalog number 6276-1-325. || Howmedica Osteonics Corp, Stryker Ireland, Carrighwohill Sterile. || Intended Use: For primary or revision total hip arthroplasty and severe proximal bone loss. Stems are intended to be used with Howmedica Osteonics femoral heads, unipolar and bipolar components, and acetabular components. Conditions for which product may be appropriate for use: rheumatoid arthritis, correction of deformity, non-inflammatory degenerative joint disease, revision surgery, treatment of non-union, fracture of proximal femur with head involvement.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

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