BEUDAMED
    FDA Recall Terminated

    Steinmann Pin, packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville, VA LLC 22911*** Models: 1620-109 1636-509 1620-509 1640-509 1620-609 1648-509 1620-709 1648-509T 1624-109 1648-609 1624-509 1648-609T 1624-509T 1628-509 1632-509 1632-609 A smooth or threaded wire / pin that may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

    Recall: Z-2158-2013 · Initiated August 12, 2013

    Recall

    Recall Number
    Z-2158-2013
    Event Number
    66029
    Firm
    MicroAire Surgical Instruments, LLC
    FEI Number
    2020601
    Product Code
    HTY
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    August 12, 2013
    Posted
    September 4, 2013
    Terminated
    February 12, 2014
    Address
    3590 Grand Forks Blvd, Charlottesville, VA, 22911-9001

    Description

    Steinmann Pin, packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville, VA LLC 22911*** Models: 1620-109 1636-509 1620-509 1640-509 1620-609 1648-509 1620-709 1648-509T 1624-109 1648-609 1624-509 1648-609T 1624-509T 1628-509 1632-509 1632-609 A smooth or threaded wire / pin that may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

    Reason

    A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility

    Action

    MicroAire Surgical LLC sent an Urgent Medical Device Recall letter dated August 12, 2013, to all affected customers. The letter advised consignees recover and quarantine the affected product so that it does not make it into the surgical process. Customers were instructed to either return affected product to MicroAire for inspection or they could inspect the product for the defect by looking at the seal area on the inside sterile package (short non-chevron side). The recalling firm further advised distributors to contact all of their customers to recover and quarantine the product so that it does not make it into the surgical process. Customers with questions were instructed to call 434-975-8370. For questions regarding this recall call 434-975-8370.

    Distribution

    Worldwide Distribution - USA (nationwide) and internationally to Australia, Ireland, Canada, Netherlands, Sweden, Japan, and United Kingdom.

    Quantity

    15786 total units