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Lower risk Medical device recall · FDA · Published July 23, 2021

BioMimetic Therapeutics AUGMENT Kit Recall: Wrong Vial Tray Hazard

BioMimetic Therapeutics recalls AUGMENT Injectable Kit (Model K30003010, Lot 1706343) due to incorrect vial tray packaging. This may cause improper use during injections.

🇺🇸 FDA recall #Z-2335-2021Medical deviceBioMimetic Therapeutics ›
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Recalling firmBioMimetic Therapeutics, LLC389 Nichol Mill Ln # A · Franklin, TN 37067-4882
✎ GovInfoNow plain-language explainer

What happened, in plain English

BioMimetic Therapeutics is recalling their AUGMENT Injectable Kit (Model K30003010, Lot 1706343) because it contains the wrong vial tray. This could lead to improper injection technique if the kit is used without the correct tray. Read more at govinfonow.com/recall/62163-biomimetic-therapeutics-augment-kit-recall-wrong-vial-tray-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/62163-biomimetic-therapeutics-augment-kit-recall-wrong-vial-tray-hazard · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2335-2021

Cite this page

“BioMimetic Therapeutics AUGMENT Kit Recall: Wrong Vial Tray Hazard.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/62163-biomimetic-therapeutics-augment-kit-recall-wrong-vial-tray-hazard. Based on FDA recall #Z-2335-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2335-2021%22&limit=1).

Why it’s dangerous

The kit includes an incorrect vial tray, which could cause improper injection technique. This might lead to incorrect dosing or ineffective treatment if the user is not using the correct tray.

Who’s affected

Users of the AUGMENT Injectable Kit (Model K30003010, Lot 1706343) who are administering injections. Those with medical conditions requiring precise injection techniques may be at slightly higher risk.

How to tell if you have this one

Check for the model number K30003010 and lot number 1706343 on the packaging. The recall applies to the AUGMENT Injectable Kit, 3cc, sold by BioMimetic Therapeutics.

  • Brand
    BioMimetic Therapeutics
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Package Details

    Verify the model number K30003010 and lot number 1706343 on the packaging to confirm if the kit is affected.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 24 states.

Alaska: named in the noticeAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: named in the noticeNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution in the states of AK, CA, CO, FL, GA, IA, ID, IL, IN, MA, MI, MN, NC, NJ, NM, NY, OH, OR, PA, TX, UT, VA, WA, and WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alaska, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Massachusetts, Michigan, Minnesota, New Jersey, New Mexico, New York, North Carolina, Ohio, Oregon, Pennsylvania, Texas, Utah, Virginia, Washington, Wisconsin.

Recall timeline

FDA terminated this recall 3.1 years after the firm started it.

1. Firm started the recall: Jul 23, 202112. FDA classified it Class II: Aug 23, 202123. Published in FDA’s Enforcement Report: Sep 1, 202134. FDA terminated the recall: Sep 4, 2024420212024
  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 recall dangerous?

The recall is for a packaging issue that could lead to improper injection technique, but it does not pose a risk of serious injury or death.

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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-2335-2021 (July 23, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2335-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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