Food, drugs, devices › MicroAire Surgical Instruments, LLC
Device recall: Steinmann Pin, packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouc
MicroAire Surgical Instruments, LLC (Charlottesville, VA) initiated this device recall on 12 Aug 2013; FDA lists 2 product records under event 66029, classified Class II.
FDA defines Class II as 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. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 12 Feb 2014. Initiation: voluntary: firm initiated. MicroAire Surgical Instruments, LLC has 12 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
MicroAire Surgical Instruments, LLC, Charlottesville, VA.
Reason for recall
"A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility"
Distribution
"Worldwide Distribution - USA (nationwide) and internationally to Australia, Ireland, Canada, Netherlands, Sweden, Japan, and United Kingdom."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2158-2013 | Steinmann Pin, 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… | 15786 total units | Class II | Terminated | 11 Sep 2013 |
| 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. 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… | 15786 total units | Class II | Terminated | 11 Sep 2013 |
Context
Other enforcement events for MicroAire Surgical Instruments, LLC
All 12 events for MicroAire Surgical Instruments, LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - USA (nationwide) and internationally to Australia, Ireland, Canada, Netherlands, Sweden, Japan, and United Kingdom."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 12 Feb 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.