Kirschner-Wire (K-Wire)
Medical device recall Z-2159-2013. Published in FDA’s Enforcement Report on Sep 11, 2013.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 11, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 15786 total units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
15786 total units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,990 characters
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…
FDA’s list runs to 5,690 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution - USA (nationwide) and internationally to Australia, Ireland, Canada, Netherlands, Sweden, Japan, and United Kingdom.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Aug 12, 2013.
- FDA classified it on Sep 4, 2013.
- FDA’s Enforcement Report published it on Sep 11, 2013.
- FDA terminated it on Feb 12, 2014.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- MicroAire Surgical Instruments, LLC, of Charlottesville, VA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 5,690 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.