The Recall Desk

FDA (Devices) recall action 66029

MicroAire Surgical Instruments, LLC recalled 2 products on 2013-09-11

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2013-09-11
Critical
0
Units
31,572

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • HighFDA (Devices)··2013-09-11

    MicroAire Steinmann Pins Recalled Due to Potential Sterility Compromise

    MicroAire Surgical Instruments is recalling Steinmann Pins because defective pouch seals may compromise sterility. The recall affects 15,786 units distributed worldwide.

    Product
    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 1636-509 162
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-09-11

    MicroAire Kirschner-Wire Recall Due to Defective Sterile Pouch Seals

    MicroAire Surgical Instruments is recalling Kirschner-Wires because defective pouch seals may compromise sterility. The recall affects 15,786 units distributed worldwide.

    Product
    Kirschner-Wire (K-Wire), 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-
    Category
    Distribution
    0 states