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Unrated Medical device recall · FDA · Published September 10, 2018

Howmedica Sterile Knee Pins: Risk of Sterile Barrier Compromise

Howmedica recalls sterile knee pins (DIA 3.2mm LNTH 89mm) due to potential outer pouch barrier compromise. Affected items were sold with lot SC22130X expiring August 2023. No remedy specified in recall.

🇺🇸 FDA recall #Z-0373-2019Medical deviceHowmedica ›
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Recalling firmHowmedica Osteonics Corp.325 Corporate Dr · Mahwah, NJ 07430-2006
✎ GovInfoNow plain-language explainer

What happened, in plain English

Howmedica recalls sterile knee pins used in surgeries for potential compromise of the sterile packaging. This could lead to infection risks if the packaging is breached during use. The recall affects specific lot numbers sold through medical suppliers. Read more at govinfonow.com/recall/69886-howmedica-sterile-knee-pins-risk-of-sterile-barrier-compromise.

Source Summary by GovInfoNow · govinfonow.com/recall/69886-howmedica-sterile-knee-pins-risk-of-sterile-barrier-compromise · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0373-2019

Cite this page

“Howmedica Sterile Knee Pins: Risk of Sterile Barrier Compromise.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69886-howmedica-sterile-knee-pins-risk-of-sterile-barrier-compromise. Based on FDA recall #Z-0373-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0373-2019%22&limit=1).

Why it’s dangerous

The outer sterile pouch may become damaged during handling or storage, potentially allowing contaminants to enter the packaging. This could lead to infection if the pins are used without proper sterility.

Who’s affected

Surgical teams and hospitals that used the specific lot number SC22130X of the sterile knee pins (DIA 3.2mm LNTH 89mm) between 2022 and 2023. Patients undergoing knee surgery with these pins are at risk if the packaging is compromised.

How to tell if you have this one

Check for the lot number SC22130X on the packaging, which expires August 2023. The pins are labeled as DIA 3.2mm LNTH 89mm with reference number 7650-2038A.

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

What to do — step by step

  1. Check Packaging Details

    Look for lot number SC22130X and expiration date August 2023 on the packaging.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 6 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: named in the noticeMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: nationwidePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide in the states of AL, FL, IL, MI, NJ & OH.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Florida, Illinois, Michigan, New Jersey, Ohio.

Recall timeline

FDA terminated this recall 2 years after the firm started it.

1. Firm started the recall: Sep 10, 201812. FDA classified it Class II: Nov 2, 201823. Published in FDA’s Enforcement Report: Nov 14, 201834. FDA terminated the recall: Aug 31, 2020420182020
  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-0373-2019 (September 10, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0373-2019 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.
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