FDA recall Z-0412-2018

Product

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)

Distribution

US Distribution.

Key facts

Status

Terminated

Initiation date

2017-05-22

Report date

2018-02-07

Termination date

2018-08-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Charlottesville, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0412-2018