Events

Recall of Inion CPS Baby

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Craniomaxillofacial Division.

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
    55861
  • Event Risk Class
    Class 2
  • Event Number
    Z-0679-2011
  • Event Initiated Date
    2010-04-14
  • Event Date Posted
    2010-12-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94815
  • 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
    Plate, bone - Product Code JEY
  • Reason
    Inadequate instructions for use. the stated strength retention is ambiguous and the maximum immersion time of the plates/meshed is not defined.
  • Action
    Stryker issued an "URGENT MEDICAL DEVICE CORRECTION" letter dated April 14, 2010. The notice informed users of the change in the instructions for use (IFU), and included a copy of the revised IFU. The consignees were informed that the affected product does not need to be returned. Stryker can be contacted about this action at 877-534-2464 (option "Regulatory Affairs", reference Product Field Action #2009-445)

Device

Inion CPS Baby
  • Model / Serial
    Lot numbers of 0700000 and above.
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution: Throughout the US
  • Product Description
    1.5 mm Inion CPS Baby, 1.5 x 6 mm screw, REF SCR-1221, sterile, Manufacturer, INION Oy, Finland.
  • Manufacturer
    Stryker Craniomaxillofacial Division

Manufacturer

Stryker Craniomaxillofacial Division
  • Manufacturer Address
    Stryker Craniomaxillofacial Division, 750 Trade Centre Way, Ste 200, Portage MI 49002-0482
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA