Kirschner-Wire — Class II medical device recall Z-2159-2013
Terminated recall by MicroAire Surgical Instruments, LLC, reported 2013-09-11, distributed nationwide. A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise
| Recall number | Z-2159-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | MicroAire Surgical Instruments, LLC, Charlottesville, VA, United States |
| Recall initiated | 2013-08-12 |
| Classified | 2013-09-04 |
| Reported by FDA | 2013-09-11 |
| Terminated | 2014-02-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, GB, IE, JP, NL, SE |
| Quantity | 15,786 units |
| Reason classes | sterility, packaging |
| Lot numbers | 0213215911, 0213215913, 0213216016, 0213216017, 0213216019, 0213216020, 0213216080, 0213216081, 0213216245, 0213216298, 0213216299, 0213216300, 0213216400, 0213216404, 0213216405, 0213216451, 0213216517, 0213216553, 0213216554, 0213216555, 0213216556, 0213216596, 0213216599, 0213216601, 0213216726, 0213216727, 0213216729, 0213216741, 0213216742, 0213216743, 0213216745, 0213216746, 0213216747, 0213216976, 0213216984, 0213216988, 0213217005, 0213217030, 0213217031, 0213217104 and 271 more |
| Model numbers | 1620-109, 1620-509, 1620-609, 1620-709, 1624-109, 1624-509, 1624-509T, 1628-509, 1632-509, 1632-609A, 1636-509, 1640-509, 1648-509, 1648-509T, 1648-609, 1648-609T |
Product
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.
Reason for recall
A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2159-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.