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U.S. Department of Health and Human Services

Enforcement Report - Week of September 11, 2013

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Product # Lot Number 1620-109 0213216244 1620-109 0213216804 1620-109 0313217447 1620-109 0413219296 1620-109 0413219479 1620-109 0613222208 1620-509 0213216077 1620-509 0213216598 1620-509 0213216740 1620-509 0313217912 1620-509 0313217980 1620-509 0413219446 1620-509 0413219514 1620-509 0513220340 1620-509 0613222209 1620-509 0613222677 1620-509 0613222950 1620-609 0213216021 1620-609 0213216987 1620-609 0313218036 1620-609 0413218860 1620-709 0313217801 1620-709 0413218861 1620-709 0513220659 1620-709 0613222204 1620-709 0613222465 1620-709 0613223531 1620-709 0713224375 1624-109 0213216721 1624-109 0313218583 1624-109 0413219836 1624-109 0413219934 1624-109 0613222761 1624-109 0713223840 1624-509 0213216018 1624-509 0213217203 1624-509 0313217576 1624-509 0313218461 1624-509 0413219480 1624-509T 0213215841 1628-509 0213217207 1628-509 0413219845 1628-509 0513220335 1628-509 0513220422 1628-509 0613222210 1632-509 0213216079 1632-509 0213216820 1632-509 0313218668 1632-509 0313218715 1632-509 0513220951 1632-509 0613222467 1632-509 0613223364 1632-609 0413219600 1636-509 0313218458 1636-509 0413218937 1640-509 0213216975 1640-509 0213216985 1640-509 0313217640 1640-509 0313217911 1640-509 0413219741 1640-509 0413219936 1640-509 0513220770 1648-509 0213216078 1648-509T 0213216803 1648-609 0213216295 1648-609 0513221947 1648-609T 0413220144 Class II A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility 15786 total units Z-2158-2013
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. 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 Class II A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility 15786 total units Z-2159-2013
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