FDA-Device2018-02-07Class II
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
MicroAire Surgical Instruments, LLC
Hazard
One lot was found to contain both the correct twist drill (1.6mm) as well as an incorrect twist drill (2.0mm)
Sold states
US Distribution.
Affected count
42
Manufactured in
3590 Grand Forks Blvd, Charlottesville, VA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0412-2018Don't want to check this manually?
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