FDA Device recall Z-2159-2013
Kirschner-Wire (K-Wire), packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit
- FDA Device
- Class II
- terminated
- Published 2013-09-11
On 2013-09-11 the FDA classified a Class II recall of Kirschner-Wire (K-Wire), packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit by Microaire Surgical Instruments, citing A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2159-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-12 |
| Published | 2013-09-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Microaire Surgical Instruments |
| Distribution | US |
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
A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility
Identifiers
| code_info | Product # Lot Number 1600-020 0213215913 1600-020 0413220145 1600-020…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2159-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.