Lower risk Medical device recall · FDA · Published September 13, 2018

Arthrex 3.2mm Proximal Reamer Recall: Potential Breakage During Use

Arthrex recalls 3.2mm Proximal Reamer/Cannulated Drills from FibuLock Nail System packs due to potential breakage during use. Affected units include specific part numbers and serial lots.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0442-2019Medical device Arthrex ›

Lower-risk recall

There is potential to break during use.

Take action

Contact the company

Recalling firmArthrex, Inc.1370 Creekside Blvd · Naples, FL 34108-1945

✎ GovInfoNow plain-language explainer

Arthrex is recalling 3.2mm Proximal Reamer/Cannulated Drills that come with FibuLock Nail System packs because they might break during use. This could lead to complications if the device breaks while being used in medical procedures. Read more at govinfonow.com/recall/69868-arthrex-3-2mm-proximal-reamer-recall-potential-breakage-during-use.

Source Summary by GovInfoNow · govinfonow.com/recall/69868-arthrex-3-2mm-proximal-reamer-recall-potential-breakage-during-use · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0442-2019

Cite this page

“Arthrex 3.2mm Proximal Reamer Recall: Potential Breakage During Use.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69868-arthrex-3-2mm-proximal-reamer-recall-potential-breakage-during-use. Based on FDA recall #Z-0442-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0442-2019%22&limit=1).

The FDA announced on Sept. 13, 2018, that Arthrex, Inc. voluntarily recalled 3.2mm Proximal Reamer/Cannulated Drills due to the potential to break during use. The device is part of the Fibulock Fibular Nail System Pack.

How to tell if you have it

Brand: Arthrex
Product: 3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack
Part #: ST6100
Lot/Serial #'s: A251217-04, A011217-01, A011217-03, A091017-05, A101017-01, A111017-01, A121017-01, A121017-02, A131017-01, A140917-01, A161017-01, A171017-01, A181017-07, A221117-01, A271117-01, A281117-02, A291117-01, A291117-03, A301117-01, A281117-01
Units affected: 832

The hazard

According to the FDA, there is potential for the 3.2mm Proximal Reamer/Cannulated Drill to break during use.

Context

GovInfoNow's records show Arthrex, Inc. has had 12 other recalls on record since Oct. 3, 2017. Other recent recalls of similar products include Arthrex Small Joint OATS Sets Recalled Due to Wrong Reamer Size Packaging (Nov. 2, 2022), Arthrex K-Wire 1.35mm x 170mm: Incorrect Size Risk (March 25, 2022), and Arthrex Suture Anchor Recall: Not Sterilized Due to Packaging Seal (June 14, 2021). Other recent recalls of similar products include Zimmer Off-Axis Alliance Glenoid Reamer Guide Recall: Plastic Guide Breakage Risk (May 20, 2026), Zimmer Off-Axis Alliance Glenoid Reamer Guide Recall: Plastic Guides May Cause Breakage (May 20, 2026), and Acumed Hexalob Screw Recall: Risk of Breakage During Wrist Fixation (May 28, 2026).

How to tell if you have this one

Check if your FibuLock Nail System pack includes the 3.2mm Proximal Reamer/Cannulated Drill with part number ST6100. Affected units have specific serial numbers listed in the recall notice.

Brand
Arthrex
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify if your FibuLock Nail System pack contains the 3.2mm Proximal Reamer/Cannulated Drill with part number ST6100.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 30 states.

FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Florida, Georgia, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nevada, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Washington, Wisconsin.

Recall timeline

FDA published this recall 2 months after the firm started it.

Sep 13, 2018Firm started the recall
Nov 9, 2018FDA classified it Class II
Nov 21, 2018Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/69868-arthrex-3-2mm-proximal-reamer-recall-potential-breakage-during-use">Arthrex 3.2mm Proximal Reamer Recall: Potential Breakage During Use (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0442-2019 (September 13, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0442-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.