Reported Feb 7, 2018 · Terminated

SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054-010, STERILE This product line is intended for use in…

MicroAire Surgical Instruments, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: MicroAire Surgical Instruments, LLC · 3590 Grand Forks Blvd · Charlottesville, VA · 22911-9006

Is this the product you have?

  • 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
Lot codes and dates
  • LIT 0317305390
Amount recalled
42

Why it was recalled

One lot was found to contain both the correct twist drill (1.6mm) as well as an incorrect twist drill (2.0mm)

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 29, 2018 · Data as of Sep 19, 6:48 PM UTC

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