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

Recall date

May 22, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0412-2018

FDA classification

Class II

Brand / firm

MicroAire Surgical Instruments, LLC

Sold / distributed

US Distribution.

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)

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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