Events

Recall of Device Recall Stryker SmartLife Large Aseptic Housing (7126120000)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Instruments Div. of Stryker Corporation.

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
    76739
  • Event Risk Class
    Class 2
  • Event Number
    Z-1886-2017
  • Event Initiated Date
    2017-02-28
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154068
  • 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
    Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
  • Reason
    Stryker instruments issued a notice of correction for an update to cleaning practices for the stryker smartlife large aseptic housings following complaints of deterioration to the housing and the top and bottom housing separating at the weld. using cleaning practices outside of the hifu could lead to housing separating at the weld.
  • Action
    Stryker Instruments issued a written corrective notice via mail including a reminder to follow the IFU cleaning procedures for the Stryker SmartLife Large Aseptic Housings (7126-120-000). A small subset of customers have experienced product issues based on cleaning practices that are causing a deterioration of the housing, and speration of the top and bottom of the housing at the weld. Customers are instructed as follows: Several factors can adversely influence the structural integrity of the device. Below are some suggestions for you to review from the Heavy Duty Care Instructions/Instructions for Use to help reduce undue strain on the housing material: " Stryker recommends following sterilization/autoclaving instructions in the Care Instructions. " Stryker has identified that some customers are applying a pre-treatment to the device, please note that the Care Instructions advise the following that pertain to the application of pretreatments (Reference Page 12 of the Heavy Duty Care Instructions): ALWAYS make sure the detergent solution is completely rinsed from the interior and exterior of the equipment before drying the equipment. ALWAYS prepare the detergent solution according to the manufacturers recommendations. Pay particular attention to the concentration used and the total dispersion. " Stryker recommends when using an auto-washer, assure the appropriate parameters (rinse time/settings) are used as instructed in the Care Instructions (Reference Page 21 of the Heavy Duty Care Instructions). Additionally: Unload the washer-disinfector and visually inspect the equipment for remaining soil or detergent solution. If soil or detergent solution remains, repeat the cleaning procedure using fresh detergent solution. Utilizing cleaning practices outside of the IFU could lead to the housing separating at the weld. The health risk associated with the separation of the housing at the weld, is a potential breach in sterility, which may requ

Device

Device Recall Stryker SmartLife Large Aseptic Housing (7126120000)
  • Model / Serial
    Manufacture Start Date for Affected Lots: 18-Mar-2015 Manufacture End Date for Affected Lots: 31-Jan-2017
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Domestic: None Foreign: France, Germany
  • Product Description
    Stryker SmartLife Large Aseptic Housing (7126-120-000)
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • Manufacturer Address
    Stryker Instruments Div. of Stryker Corporation, 4100 E Milham Ave, Portage MI 49002-9704
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA