Events

Recall of Small Bone Innovations (see also Product Description)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Small Bone Innovations, Inc..

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
    66362
  • Event Risk Class
    Class 2
  • Event Number
    Z-0098-2014
  • Event Initiated Date
    2013-09-06
  • Event Date Posted
    2013-10-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122155
  • 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, elbow, hemi-, radial, polymer - Product Code KWI
  • Reason
    The recall was initiated due to an increased risk of implants breaching the sterile pouches inside the shrink-wrapped box.
  • Action
    Email correspondence and a notification letter, dated September 6, 2013, were sent to users requesting the immediate return of affected devices. Another notification letter, dated December 20, 2013 was also sent for recall of the additional devices after the recall was expanded.

Device

Small Bone Innovations (see also Product Description)
  • Model / Serial
    all item numbers and lot numbers.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Canada and Mexico.
  • Product Description
    Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rHead Radial Stem Lateral Assembly, rHead Radial Stem 6mm Collar, rHead Recon Radial Stem 6mm Collar, rHead Radial Stem Lateral Assembly 6mm Collar, rHead Standard Extended Stem, rHead Radial Stem Plasma Coated, rHead Recon Radial Stem Plasma Coated, rHead Radial Stem 6mm Collar Plasma Coated, rHead Recon Radial Stem 6mm Collar Plasma Coated, uHead Ulnar Stem Standard, uHead Ulnar Stem 20mm Collar packaged in a sterile pouch inside a shrink-wrapped box. || The recall was expanded on December 20, 2013 to include the following devices: rHead lateral assembly, radial head implant, sizes 2 through 4, Uni-elbow lateral assembly, radial implant assembly, sozes 2 through 4, ReMotion Left, large distal radial component, x-small, small, medium, and large, ReMotion Right, distal radial component, x-small, small, medium, and large.
  • Manufacturer
    Small Bone Innovations, Inc.

Manufacturer

Small Bone Innovations, Inc.
  • Manufacturer Address
    Small Bone Innovations, Inc., 1711 S Pennsylvania Ave, Morrisville PA 19067-2507
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA