Events

Recall of Device Recall Solar Shoulder Humeral Stem

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
    50485
  • Event Risk Class
    Class 2
  • Event Number
    Z-0888-2009
  • Event Initiated Date
    2008-11-13
  • Event Date Posted
    2009-01-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-01-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75470
  • 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, shoulder - Product Code KWS
  • Reason
    Stryker orthopaedics became aware of a visual defect in certain blister packages of certain devices.
  • Action
    Recall notification letters were sent via Federal Express on November 21, 2008 to Stryker Branches/Agencies, Hospital Risk Management, Chief of Orthopaedics and Surgeon. The letters explained the problem and indicated that there are no risk factors. Contact Stryker Orthopaedics for additional information at 1-201-831-5718.

Device

Device Recall Solar Shoulder Humeral Stem
  • Model / Serial
    CAT. NO.5351-4103, SHOULDER - HUMERAL STEM 7mm , LOT CODE XKRMHE, CAT. NO. 5351-4105 SHOULDER - HUMERAL STEM 9mm, LOT CODE 8ETMJE,  CAT. NO. 5351-4105 SHOULDER - HUMERAL STEM 9mm LOT CODE 8EYMJE,  CAT. NO. 5351-4107 SHOULDER - HUMERAL STEM 11mm LOT CODE V45MKE,   CAT. NO. 5351-4108 SHOULDER - HUMERAL STEM 12mm LOT CODE VV3MKE,  CAT. NO. 5351-4108 SHOULDER - HUMERAL STEM 12mm LOT CODE VV4MKE,   CAT. NO. 5351-4109 SHOULDER - HUMERAL STEM 13mm LOT CODE VWHMKE,  CAT. NO. 5351-4110 SHOULDER - HUMERAL STEM 14mm LOT CODE HTXMKE,  CAT. NO. 5351-4110 SHOULDER - HUMERAL STEM 14mm LOT CODE T7TMKE,   CAT. NO. 5351-4113 SHOULDER - HUMERAL STEM 17mm LOT CODE KKHMKE and  CAT. NO. 5351-4205 SHOULDER - HUMERAL 200mmX9mm LOT CODE MT9MKE
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide. OUS: Australia, Canada, Japan, Argentina, Brazil, Germany, Spain, Columbia, Guatemala and Sweden.
  • Product Description
    Solar Shoulder Humeral Stem || These devices are modular components of a total shoulder system. These humeral stems are intended for use with humeral heads and glenoid components in primary or revision total shoulder arthroplasty.
  • 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