Arthrex, Inc. recalls 3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack. FibuLock Nail Procedu…

Recall date

September 13, 2018

Source

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

Recall number

Z-0442-2019

FDA classification

Class II

Brand / firm

Arthrex, Inc.

Sold / distributed

Distributed throughout the U.S. to the following states: NC, CA, NJ, CO, NV, UT, LA, KY, OH, AZ, MO, MN, TN, NY, WI, MA, PA, TX, IL, PA, AR, FL, IA, MI, AL, SD, OR, WA, MD, KS, and GA.

Why it was recalled

There is potential to break during use.

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

What was recalled

3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack. FibuLock Nail Procedure Pack: Contains instrumentation for the implantation of the FibuLock implant. Contents include: Actuation Driver, 6.2mm Reamer, 3.2mm Reamer, 2 mm Drill, Spade Tip Guide Wire, and 1.6mm x 12 K-Wire.