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Lower risk Medical device recall · FDA · Published February 24, 2021

Arthrex 5.0mm Drill Bit Recall: Incorrect Color Indicator

Arthrex recalls 5.0mm cannulated drill bits with incorrect color indicators for foot and ankle procedures. Affected units have product code AR-8770-02 and lot number 032052.

🇺🇸 FDA recall #Z-1310-2021Medical deviceArthrex ›
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Recalling firmArthrex, Inc.1370 Creekside Blvd · Naples, FL 34108-1945
✎ GovInfoNow plain-language explainer

What happened, in plain English

Arthrex is recalling 5.0mm cannulated drill bits that have an incorrect color indicator on the shaft. This could lead to improper use during foot and ankle procedures if the wrong bit is selected. Read more at govinfonow.com/recall/63239-arthrex-5-0mm-drill-bit-recall-incorrect-color-indicator.

Source Summary by GovInfoNow · govinfonow.com/recall/63239-arthrex-5-0mm-drill-bit-recall-incorrect-color-indicator · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1310-2021

Cite this page

“Arthrex 5.0mm Drill Bit Recall: Incorrect Color Indicator.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63239-arthrex-5-0mm-drill-bit-recall-incorrect-color-indicator. Based on FDA recall #Z-1310-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1310-2021%22&limit=1).

Why it’s dangerous

The color indicator on the drill bit shaft is incorrect, which may cause the wrong bit to be used during procedures. This could lead to improper surgical outcomes if the wrong size or type of drill bit is selected.

Who’s affected

Surgical professionals and medical facilities that use Arthrex drill bits for foot and ankle procedures. Those using the specific product code AR-8770-02 with lot number 032052 are most at risk.

How to tell if you have this one

Check for product code AR-8770-02 and lot number 032052 on the drill bit packaging or label. The color indicator on the proximal end of the shaft is incorrect.

  • Brand
    Arthrex
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the product code and lot number on the drill bit to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 4 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: named in the noticeORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: nationwideFL

FDA distribution: “US Nationwide distribution in the states of Ohio, Oregon, Tennessee, Texas.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Ohio, Oregon, Tennessee, Texas.

Recall timeline

FDA terminated this recall 2.2 years after the firm started it.

1. Firm started the recall: Feb 24, 202112. FDA classified it Class II: Mar 26, 202123. Published in FDA’s Enforcement Report: Apr 7, 202134. FDA terminated the recall: May 2, 2023420212023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

✎ GovInfoNow

Questions people ask

Is this drill bit dangerous to use?

The recall is due to an incorrect color indicator, which may lead to improper use during procedures. It is not inherently dangerous but requires verification to ensure correct usage.

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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-1310-2021 (February 24, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1310-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA