Arthrex 3.2mm Proximal Reamer Recall: Potential Breakage During Use

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

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✎ GovInfoNow plain-language explainer

What happened, in plain English

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.

Why it’s dangerous

The 3.2mm Proximal Reamer/Cannulated Drill could break during use, which might cause complications in the surgical procedure. This breakage could lead to issues like incomplete implantation or damage to surrounding tissues.

Who’s affected

Medical professionals using the FibuLock Nail System packs for orthopedic procedures are most at risk. Patients receiving these implants may also be affected if the device breaks during surgery.

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.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The recall is due to potential breakage during use, which could cause complications in surgical procedures.

What part numbers are affected?

Affected units have part number ST6100 and specific serial numbers listed in the recall notice.

Is there a fix for this issue?

The recall record does not mention a remedy or fix for this issue.

Take action

Contact Arthrex

We’ve drafted a message you can send Arthrex to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0442-2019 — Arthrex Arthrex

Hello,

I own a Arthrex that is covered by recall Z-0442-2019 from Arthrex.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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.

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