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MicroAire Surgical Instruments, LLC recalls Kirschner-Wire (K-Wire), packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales
Recalled September 11, 2013 · FDA recall Z-2159-2013 · MicroAire Surgical Instruments
Hazard
A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility · FDA Class II
Units
15786 total units
Sold at
Worldwide Distribution - USA (nationwide) and internationally to Australia, Ireland, Canada, Netherlands, Sweden, Japan, and United Kingdom.
Description
A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility
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 1636-509 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.
Manufacturer(s)
MicroAire Surgical Instruments, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →