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U.S. Department of Health and Human Services

Enforcement Report - Week of September 11, 2013

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Product Detail

Product Description 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.
Recall Number Z-2159-2013
Classification Class II
Code Info 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 0313217846 1600-635 0313218459 1600-635 0413219158 1600-635 0413219525 1600-635 0513220425 1600-635 0513220954 1600-635 0513221729 1600-635 0613222381 1600-635 0613222869 1600-635 0613223527 1600-645 0213216080 1600-645 0213216451 1600-645 0213216984 1600-645 0313217353 1600-645 0313217848 1600-645 0313218076 1600-645 0313218305 1600-645 0313218669 1600-645 0313218716 1600-645 0413219160 1600-645 0413219448 1600-645 0413219742 1600-645 0413219951 1600-645 0413220146 1600-645 0513220590 1600-645 0513220953 1600-645 0513221372 1600-645 0513221561 1600-645 0513221822 1600-645 0613222033 1600-645 0613222463 1600-645 0613222541 1600-645 0613222953 1600-645 0613223244 1600-645 0713223634 1600-645T 0213216742 1600-645T 0313218704 1600-645T 0413219599 1600-645T 0413219841 1600-645T 0613222203 1600-654 0213216746 1600-654 0213217104 1600-654 0313217803 1600-654 0313218585 1600-654 0413219516 1600-654 0413220142 1600-654 0513220336 1600-654 0513221624 1600-654 0613222464 1600-662 0213216400 1600-662 0213216517 1600-662 0213217005 1600-662 0213217205 1600-662 0313217759 1600-662 0313218160 1600-662 0313218673 1600-662 0413219098 1600-662 0413219603 1600-662 0413219974 1600-662 0513220657 1600-662 0513221435 1600-662 0513221728 1600-662 0613222123 1600-662 0613222760 1600-662 0613223180 1600-662 0713224021 1600-662T 0213216741 1600-662T 0213217204 1600-662T 0313218037 1600-662T 0313218283 1600-662T 0313218706 1600-662T 0413218858 1600-662T 0413219447 1600-662T 0413219839 1600-662T 0513220341 1600-662T 0613222382 1600-662T 0613222680 1600-662T 0613223281 1600-935 0213216729 1600-935 0313217478 1600-935 0313218281 1600-935 0413218862 1600-935 0513220660 1600-9355 0213216016 1600-9355 0413219601 1600-935T 0213217288 1600-945 0213216020 1600-945 0213216726 1600-945 0213217208 1600-945 0313218075 1600-945 0313218703 1600-945 0413219154 1600-945 0413219840 1600-945 0513220424 1600-945 0513220702 1600-945 0513221176 1600-945 0613222279 1600-945 0613222881 1600-945 0613223477 1600-9455 0213216727 1600-9455 0213217143 1600-9455 0613222278 1600-9455 0613222380 1600-954 0313217578 1600-954 0313218705 1600-954 0413219844 1600-954 0513220339 1600-954 0513220570 1600-9545 0313217371 1600-9545 0513220337 1600-9545 0513220877 1600-9545 0513221007 1600-962 0213216298 1600-962 0213216747 1600-962 0213217107 1600-962 0313217909 1600-962 0313218297 1600-962 0413219159 1600-962 0413219935 1600-962 0513220701 1600-962 0513221174 1600-962 0613222205 1600-962 0613222679 1600-962 0613223088 1600-9625 0213216596 1600-9625 0313218284 1600-9625 0413219295 1600-9625 0513220703 1600-9625 0513221005 1600-9625 0513221623 1600-9625 0613222280 1600-962T 0213216553 1600-962T 0313217649 1600-962T 0313217845 1600-962T 0313218280 1600-962T 0313218672 1600-962T 0413219740 1600-962T 0413219843 1600-962T 0413220143 1600-962T 0513220571 1600-962T 0513220874 1600-962T 0513221218 1600-962T 0613222207 1604-145 0213216554 1604-145 0213216988 1604-145 0313218670 1604-145 0413219097 1604-145 0413219837 1604-145 0513220334 1604-145 0513220504 1604-145 0513221820 1604-145 0613223277 1604-145 0613223362 1604-145 0713223841 1604-154 0413219984 1604-162 0213216745 1604-162 0313217579 1604-162 0313218667 1604-162 0313218714 1604-162 0413218801 1604-162 0413218857 1604-162 0413219842 1604-162 0513221173 1604-162 0613222212 1604-162 0613222282 1604-162 0613222675 1604-162 0613222832 1604-162 0713223956
Product Distributed Qty 15786 total units
Reason For Recall A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility

Event Detail

Event Id 66029
Product Type Devices
Status Ongoing
Recalling Firm MicroAire Surgical Instruments, LLC
City Charlottesville
State VA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-12
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA (nationwide) and internationally to Australia, Ireland, Canada, Netherlands, Sweden, Japan, and United Kingdom.
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