Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 11, 2013
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
A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
MicroAire Surgical Instruments, LLC recalled Kirschner-Wire (K-Wire), packed in a clear tube with end caps, tubes packed in a sterile … - a moderate-severity action.
Kirschner-Wire (K-Wire), packed in a clear tube with end caps, tubes packed in a sterile … was recalled by MicroAire Surgical Instruments, LLC in September 11, 2013. Reason: A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise…. Check the official notice for the remedy. Verify recall #Z-2159-2013 with the FDA Devices before acting.
The recall
MicroAire Surgical Instruments, LLC issued this moderate-severity FDA Devices recall-A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise….
- Moderate
- severity level
- Class II
- classification
- September 11, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2159-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2159-2013) was formally reported on September 11, 2013, with the manufacturer initiating the action on August 12, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. MicroAire Surgical Instruments, LLC is listed as the recalling firm, operating out of Charlottesville, VA. Federal records list the affected scope as 15786 total units.
The documented reason for this recall is: A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) and internationally to Australia, Ireland, Canada, Netherlands, Sweden, Japan, and United Kingdom.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
15786 total units
Related Recalls
6
3 from same agency
Product description
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2159-2013 |
| Date reported | September 11, 2013 |
| Date initiated | August 12, 2013 |
| Recalling firm | MicroAire Surgical Instruments, LLC |
| Firm location | Charlottesville, VA |
| Affected scope | 15786 total units |
| Distribution | Worldwide Distribution - USA (nationwide) and internationally to Australia, Ireland, Canada, Netherlands, Sweden, Japan, and United Kingdom. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2159-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was 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.. Recalled by MicroAire Surgical Instruments, LLC. Units affected: 15786 total units.
Why was this product recalled? ▼
A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 11, 2013. Severity: Moderate. Recall number: Z-2159-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) and internationally to Australia, Ireland, Canada, Netherlands, Sweden, Japan, and United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2159-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 11, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.