CLASS II Device recall · Reported 11 Sep 2013 · FDA Enforcement Report
Steinmann Pin recalled by MicroAire Surgical Instruments
MicroAire Surgical Instruments is recalling Steinmann Pin, distributed nationwide in the US. The recall was initiated on 12 Aug 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2158-2013
- FDA event ID
- 66029
- Recalling firm
- MicroAire Surgical Instruments, Charlottesville, VA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Aug 2013
- FDA classified
- 4 Sep 2013
- Reported
- 11 Sep 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 12 Aug 2013 | Recall initiated by company | |
| 4 Sep 2013 | Classified by FDA | +23 days |
| 11 Sep 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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 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.
Where it was distributed
Worldwide Distribution - USA (nationwide) and internationally to Australia, Ireland, Canada, Netherlands, Sweden, Japan, and United Kingdom.
Questions about this recall
Why was it recalled?
A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility
Which lots are affected?
Product # Lot Number 1620-109 0213216244 1620-109 0213216804 1620-109 0313217447 1620-109 0413219296 1620-109 0413219479 1620-109 0613222208 1620-509 0213216077 1620-509 0213216598 1620-509 0213216740 1620-509 0313217912 1620-509 0313217980 1620-509 0413219446 1620-509 0413219514 1620-509 0513220340 1620-509 0613222209 1620-509 0613222677 1620-509 0613222950 1620-609 0213216021 1620-609 0213216987 1620-609 0313218036 1620-609 0413218860 1620-709 0313217801 1620-709 0413218861 1620-709 0513220659 1620-709 0613222204 1620-709 0613222465 1620-709 0613223531 1620-709 0713224375 1624-109 0213216721 1624-109 0313218583 1624-109 0413219836 1624-109 0413219934 1624-109 0613222761 1624-109 0713223840 1624-509 0213216018 1624-509 0213217203 1624-509 0313217576 1624-509 0313218461 1624-509 0413219480 1624-509T 0213215841 1628-509 0213217207 1628-509 0413219845 1628-509 0513220335 1628-509 0513220422 1628-509 0613222210 1632-509 0213216079 1632-509 0213216820 1632-509 0313218668 1632-509 0313218715 1632-509 0513220951 1632-509 0613222467 1632-509 0613223364 1632-609 0413219600 1636-509 0313218458 1636-509 0413218937 1640-509 0213216975 1640-509 0213216985 1640-509 0313217640 1640-509 0313217911 1640-509 0413219741 1640-509 0413219936 1640-509 0513220770 1648-509 0213216078 1648-509T 0213216803 1648-609 0213216295 1648-609 0513221947 1648-609T 0413220144
Where was it sold?
Worldwide Distribution - USA (nationwide) and internationally to Australia, Ireland, Canada, Netherlands, Sweden, Japan, and United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 66029| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Kirschner-Wire (K-Wire) recalled by MicroAire Surgical Instruments | MicroAire Surgical Instruments | Sterility | Nationwide |
More recalls from MicroAire Surgical Instruments
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | SmartRelease Onyx recalled by MicroAire Surgical Instruments | MicroAire Surgical Instruments | Other | Nationwide |
| Device | CLASS II | SmartRelease Endoscopic Carpal Tunnel Release Handpiece recalled | MicroAire Surgical Instruments | Other | 26 states |
| Device | CLASS II | MicroAire SmartRelease Endoscopic System recalled | MicroAire Surgical Instruments | Sterility | Nationwide |
| Device | CLASS II | Sst Twist Drill, Standard Dia recalled by MicroAire Surgical Instruments | MicroAire Surgical Instruments | Other | VA |
| Device | CLASS II | MicroAire K-Wires recalled by MicroAire Surgical Instruments | MicroAire Surgical Instruments | Labeling Errors | VA |
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