Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Recalled by Arthrex, Inc. Due to There is potential to break during use.

Date: September 13, 2018
Company: Arthrex, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Arthrex, Inc. directly.

Affected Products

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.

Quantity: 832

Why Was This Recalled?

There is potential to break during use.

Where Was This Sold?

This product was distributed to 30 states: AL, AZ, AR, CA, CO, FL, GA, IL, IA, KS, KY, LA, MD, MA, MI, MN, MO, NV, NJ, NY, NC, OH, OR, PA, SD, TN, TX, UT, WA, WI

Affected (30 states)Not affected

About Arthrex, Inc.

Arthrex, Inc. has 28 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report