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Lower risk Medical device recall · FDA · Published October 3, 2017

Zimmer Biomet Sirus Drill 13mm Trauma Instrument Recall: Infection Risk

Zimmer Biomet recalls Sirus Drill 13mm trauma instruments due to potential infection from inadequate cleaning. Affected models include 02.00020.040. No remedy specified in recall notice.

🇺🇸 FDA recall #Z-0919-2018Medical deviceZimmer Biomet ›
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Recalling firmZimmer Biomet, Inc.1800 W Center St · Warsaw, IN 46580-2304
✎ GovInfoNow plain-language explainer

What happened, in plain English

Zimmer Biomet is recalling its Sirus Drill 13mm trauma instruments because they may not clean properly following standard instructions, risking infection during surgery. This affects surgeons and medical staff using these tools for bone preparation in trauma, hip, and shoulder procedures. Read more at govinfonow.com/recall/72916-zimmer-biomet-sirus-drill-13mm-trauma-instrument-recall-infection-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/72916-zimmer-biomet-sirus-drill-13mm-trauma-instrument-recall-infection-risk · Updated September 17, 2026 · FDA enforcement record: FDA #Z-0919-2018

Cite this page

“Zimmer Biomet Sirus Drill 13mm Trauma Instrument Recall: Infection Risk.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/72916-zimmer-biomet-sirus-drill-13mm-trauma-instrument-recall-infection-risk. Based on FDA recall #Z-0919-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0919-2018%22&limit=1).

Why it’s dangerous

The instruments may not clean adequately when following standard instructions, which can lead to infections and complications during surgery. This risk occurs because the cleaning process might not effectively remove all contaminants from the instruments.

Who’s affected

Surgeons and medical staff who use the Sirus Drill 13mm trauma instruments for bone preparation in hip, shoulder, and trauma surgeries are most at risk. Patients undergoing these procedures may also be affected if the instruments are not properly cleaned.

How to tell if you have this one

Check for the model number 02.00020.040 on the instrument. The Sirus Drill 13mm trauma instrument is used for bone preparation in hip, shoulder, and trauma surgeries.

  • Brand
    Zimmer Biomet
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Distributed in 31 states: AL, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, OR, PA, TN, TX, VA, VT, WA, WI and the District of Columbia.
Recall numberProduct, codes & lotsQuantity
Z-0918-2018Flexible Shaft hip and anatomical shoulder instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: 75.80.04; All lots457
Z-0919-2018Sirus Drill 13mm diameter trauma instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: 02.00020.040; All lots127
Based on the official FDA remedy

What to do — step by step

  1. Check Model Number

    Look for the model number 02.00020.040 on the instrument to confirm it is affected.

Where it went and when

Where it was distributed

Distributed in 31 states and D.C..

Alaska: not listedAKMaine: not listedMEVermont: yesVTNew Hampshire: not listedNHWashington: yesWAIdaho: yesIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: not listedRIMassachusetts: yesMAOregon: yesORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: not listedUTColorado: yesCONebraska: not listedNEMissouri: yesMOKentucky: yesKYWest Virginia: not listedWVVirginia: yesVAMaryland: yesMDDelaware: not listedDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: not listedARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: yesDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Distributed in 31 states: AL, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, OR, PA, TN, TX, VA, VT, WA, WI and the District of Columbia.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Missouri, New Jersey, New Mexico, New York, North Carolina, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Vermont, Virginia, Washington, Wisconsin.

Recall timeline

FDA terminated this recall 11 months after the firm started it.

1. Firm started the recall: Oct 3, 201712. FDA classified it Class II: Mar 6, 201823. Published in FDA’s Enforcement Report: Mar 14, 201834. FDA terminated the recall: Aug 20, 2018420172018
  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.

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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-0919-2018 (October 3, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0919-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on September 17, 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