Recall of KirschnerWire (KWire),

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by MicroAire Surgical Instruments, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    66029
  • Event Risk Class
    Class 2
  • Event Number
    Z-2159-2013
  • Event Initiated Date
    2013-08-12
  • Event Date Posted
    2013-09-04
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2014-02-12
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Pin, fixation, smooth - Product Code HTY
  • Reason
    A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility.
  • Action
    MicroAire Surgical LLC sent an Urgent Medical Device Recall letter dated August 12, 2013, to all affected customers. The letter advised consignees recover and quarantine the affected product so that it does not make it into the surgical process. Customers were instructed to either return affected product to MicroAire for inspection or they could inspect the product for the defect by looking at the seal area on the inside sterile package (short non-chevron side). The recalling firm further advised distributors to contact all of their customers to recover and quarantine the product so that it does not make it into the surgical process. Customers with questions were instructed to call 434-975-8370. For questions regarding this recall call 434-975-8370.

Device

  • Model / Serial
    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 Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and internationally to Australia, Ireland, Canada, Netherlands, Sweden, Japan, and United Kingdom.
  • 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.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    MicroAire Surgical Instruments, LLC, 3590 Grand Forks Blvd, Charlottesville VA 22911-9001
  • Manufacturer Parent Company (2017)
  • Source
    USFDA