Events

Recall of Device Recall Restoration Modular Hip System

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
    52713
  • Event Risk Class
    Class 3
  • Event Number
    Z-2148-2009
  • Event Initiated Date
    2009-06-26
  • Event Date Posted
    2009-09-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-07-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83773
  • 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
    Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
  • Reason
    The raw material used in the production of the unipolar adaptor sleeve and the restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by this vendor has raised concern about their supplied raw material. as a precaution and due to the potential impact on the mechanical properties of the products, st.
  • Action
    Stryker Orthopaedics issued "Urgent Product Recall" letters via Federal Express priority overnight beginning June 26, 2009 to Branches, Hospital Risk Management and Chief of Orthopaedics and Surgeons. All users are requested to examine their inventory, retrieve all affected product and return for reconciliation to Stryker Orthopaedics. Users are also requested to complete the enclosed Product Accountability Form and fax with necessary information to the firm at 1-201-831-6069. For further information, contact Stryker Orthopaedics at 1-201-831-5970.

Device

Device Recall Restoration Modular Hip System
  • Model / Serial
    Catalog number: 6276-7-015; REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ910G 15-Jan-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ910C 15-Jan-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ910C 15-Jan-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ910A 20-Jan-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ910A 20-Jan-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ910A 20-Jan-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ910D 27-Jan-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909C 09-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ827D 17-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ827D 17-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ827F 17-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ827D 17-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ827D 17-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ827F 17-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ827F 17-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ827D 17-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909F 18-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909F 18-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909H 23-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909H 23-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909H 23-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909D 24-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909E 27-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909E 27-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909E 27-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909A 02-Mar-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909G 02-Mar-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909A 02-Mar-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909A 02-Mar-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909F 18-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909F 18-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ910F 24-Mar-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ910F 24-Mar-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ827C 13-Mar-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ910E 31-Mar-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909J 30-Apr-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909J 30-Apr-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ910E 31-Mar-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909J 30-Apr-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ910E 31-Mar-2014
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution
  • Product Description
    Restoration Modular Hip System, Conical Distal Stem, 15 mm x 155 mm; Straight, Cementless Use Only. || Stryker Orthopaedics. || Intended to be used for primary or revision total hip arthroplasty as well as in the presence of sever proximal bone loss.
  • 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