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***
  • 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
Lot codes and dates
  • Product # Lot Number

    134 of 134 codes

    • 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
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 12, 2014 · Data as of Sep 19, 5:35 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.