CLASS II Device recall · Reported 7 Feb 2018 · FDA Enforcement Report
Sst Twist Drill, Standard Dia recalled by MicroAire Surgical Instruments
MicroAire Surgical Instruments is recalling Sst Twist Drill, Standard Dia. The recall was initiated on 22 May 2017 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-0412-2018
- FDA event ID
- 78687
- Recalling firm
- MicroAire Surgical Instruments, Charlottesville, VA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 May 2017
- FDA classified
- 26 Jan 2018
- Reported
- 7 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 22 May 2017 | Recall initiated by company | |
| 26 Jan 2018 | Classified by FDA | +249 days |
| 7 Feb 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
One lot was found to contain both the correct twist drill (1.6mm) as well as an incorrect twist drill (2.0mm)
Product as listed by the FDA
SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054-010, STERILE This product line is intended for use in orthopaedic surgery (large and small bone surgeries) to cut bone
Where it was distributed
US Distribution.
Questions about this recall
Why was it recalled?
One lot was found to contain both the correct twist drill (1.6mm) as well as an incorrect twist drill (2.0mm)
Which lots are affected?
LIT 0317305390
Where was it sold?
US Distribution.
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.
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