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Recall Observatory FDA recall evidence

Device product

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.

Z-2158-2013

August 12, 2013

Class II

Product summary

Firm
MicroAire Surgical Instruments, LLC
Event
Event 66029
Status
Terminated
Classification
Class II
Quantity
15786 total units
Official record key
device-enforcement:Z-2158-2013

Official wording

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

Code information: 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

Distribution pattern: Worldwide Distribution - USA (nationwide) and internationally to Australia, Ireland, Canada, Netherlands, Sweden, Japan, and United Kingdom.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    pouch in which a defective seal may compromise
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    seal may compromise sterility

Field note

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