PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: February 7, 2018 Initiated: May 22, 2017 #Z-0412-2018

Product Description

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

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)

Details

Units Affected
42
Distribution
US Distribution.
Location
Charlottesville, VA

Frequently Asked Questions

What product 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. Recalled by MicroAire Surgical Instruments, LLC. Units affected: 42.
Why was this product recalled?
One lot was found to contain both the correct twist drill (1.6mm) as well as an incorrect twist drill (2.0mm)
Which agency issued this recall?
This recall was issued by the FDA Devices on February 7, 2018. Severity: Moderate. Recall number: Z-0412-2018.