BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-0098-2014 · Reported November 6, 2013

    Enforcement

    Recall Number
    Z-0098-2014
    Event ID
    66362
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Small Bone Innovations, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 6, 2013
    Initiation Date
    September 6, 2013
    Classification Date
    October 29, 2013
    Termination Date
    March 30, 2015
    Address
    1711 S Pennsylvania Ave, N/A, Morrisville, PA, 19067-2507, United States

    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.

    Reason

    The recall was initiated due to an increased risk of implants breaching the sterile pouches inside the shrink-wrapped box.

    Code Info

    all item numbers and lot numbers.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Canada and Mexico.

    Quantity

    2036 devices