Reported Sep 11, 2013 · Terminated
Kirschner-Wire (K-Wire), packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales…
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?
- 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***
- 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
562 of 562 codes
1600-02002132159131600-02004132201451600-02005132203421600-02005132207691600-02005132209521600-02005132211141600-02005132213021600-02005132218251600-02006132223831600-02006132224621600-02102132160191600-02102132172871600-02104132188021600-02104132198381600-02105132204231600-02105132208761600-02105132210091600-02105132219481600-02106132227591600-02202132159111600-02202132165991600-02202132171051600-02203132176351600-02203132179781600-02203132185841600-02204132189361600-02204132192971600-02204132199801600-02205132208291600-0220513221303
- 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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