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FDAFDA · Food and drugs·Recall number Z-2159-2013

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.

Published September 11, 2013 · Recall initiated: August 12, 2013

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
MicroAire Surgical Instruments, LLC
Distributor
Worldwide Distribution - USA (nationwide) and internationally to Australia, Ireland, Canada, Netherlands, Sweden, Japan, and United Kingdom.
Lot
Product # Lot Number 1600-020 0213215913 1600-020 0413220145 1600-020 0513220342 1600-020 0513220769 1600-020 0513220952 1600-020 0513221114 1600-020 0513221302 1600-020 0513221825 1600-020 0613222383 1600-020 0613222462 1600-021 0213216019 1600-021 0213217287 1600-021 0413218802 1600-021 0413219838 1600-021 0513220423 1600-021 0513220876 1600-021 0513221009 1600-021 0513221948 1600-021 0613222759 1600-022 0213215911 1600-022 0213216599 1600-022 0213217105 1600-022 0313217635 1600-022 0313217978 1600-022 0313218584 1600-022 0413218936 1600-022 0413219297 1600-022 0413219980 1600-022 0513220829 1600-022 0513221303 1600-022 0613222034 1600-022 0613222678 1600-022 0613223243 1600-022 0713223715 1600-023 0213216601 1600-023 0213217285 1600-023 0313217910 1600-023 0313218074 1600-023 0313218484 1600-023 0413218804 1600-023 0413219743 1600-023 0413220193 1600-023 0513220503 1600-023 0513221006 1600-023 0513221626 1600-023 0613222540 1600-023 0613222904 1600-023 0613223365 1600-023 0713223833 1600-428 0213217031 1600-428 0313217802 1600-428 0413218859 1600-428 0513220955 1600-428 0513221177 1600-428 0513221823 1600-435 0213216017 1600-435 0213216556 1600-435 0313217847 1600-435 0313218304 1600-435 0313218674 1600-435 0413219524 1600-435 0513220338 1600-435 0513220771 1600-435 0513221437 1600-435 0613222206 1600-435 0613222830 1600-445 0213216300 1600-445 0213217030 1600-445 0313217486 1600-445 0313217982 1600-445 0313218460 1600-445 0413218932 1600-445 0413219482 1600-445 0413220192 1600-445 0513220767 1600-445 0513221373 1600-445 0513221949 1600-445 0613222384 1600-445 0613222829 1600-445 0613223467 1600-454 0213216405 1600-454 0213216976 1600-454 0213217206 1600-454 0313217485 1600-454 0313218485 1600-454 0413219153 1600-454 0413219846 1600-454 0513221175 1600-462 0213216245 1600-462 0213216743 1600-462 0213217289 1600-462 0313218035 1600-462 0313218589 1600-462 0413219157 1600-462 0413219981 1600-462 0513220875 1600-462 0513221558 1600-462 0613222281 1600-462 0613222902 1600-462 0613223525 1600-462T 0213217106 1600-462T 0413219602 1600-462T 0513221557 1600-628 0213216299 1600-628 0213216404 1600-628 0213217108 1600-628 0313217913 1600-628 0313218671 1600-628 0413219298 1600-628 0513221436 1600-635 0213216081 1600-635 0213216555 1600-635 0213217142 1600-635
Risk classification
Class II
Area (FDA)
device
Country
United States