Reported Sep 11, 2013 · Terminated
Steinmann Pin, packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit.…
MicroAire Surgical Instruments, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MicroAire Surgical Instruments, LLC · 3590 Grand Forks Blvd · Charlottesville, VA · 22911-9001
Is this the product you have?
- 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***
- ModelsA 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
1620-1091636-5091620-5091640-5091620-6091648-5091620-7091648-509T1624-1091648-6091624-5091648-609T1624-509T1628-5091632-5091632-609
- Lot codes and dates
- Product # Lot Number
134 of 134 codes
1620-10902132162441620-10902132168041620-10903132174471620-10904132192961620-10904132194791620-10906132222081620-50902132160771620-50902132165981620-50902132167401620-50903132179121620-50903132179801620-50904132194461620-50904132195141620-50905132203401620-50906132222091620-50906132226771620-50906132229501620-60902132160211620-60902132169871620-60903132180361620-60904132188601620-70903132178011620-70904132188611620-70905132206591620-70906132222041620-70906132224651620-70906132235311620-70907132243751624-10902132167211624-1090313218583
- Product # Lot Number
- Amount recalled
- 15786 total units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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