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Use caution Medical device recall · FDA · Published April 1, 2020

Howmedica Cortoss Bone Augmentation Material Recall: Risk of Nerve Damage

Howmedica recalls Cortoss Bone Augmentation Material (Catalogs 2101-0005 and 2101-0010) due to potential nerve damage and embolism from improper refrigeration.

🇺🇸 FDA recall #Z-1900-2020Medical deviceHowmedica ›
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Recalling firmHowmedica Osteonics Corp.2 Pearl Ct · Allendale, NJ 07401-1611
✎ GovInfoNow plain-language explainer

Howmedica is recalling Cortoss Bone Augmentation Material with specific catalog numbers because it was shipped without proper refrigeration. This could cause nerve damage leading to paralysis or embolism if used. Read more at govinfonow.com/recall/65588-howmedica-cortoss-bone-augmentation-material-recall-risk-of-nerve-damage.

Source Summary by GovInfoNow · govinfonow.com/recall/65588-howmedica-cortoss-bone-augmentation-material-recall-risk-of-nerve-damage · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1900-2020

Cite this page

“Howmedica Cortoss Bone Augmentation Material Recall: Risk of Nerve Damage.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65588-howmedica-cortoss-bone-augmentation-material-recall-risk-of-nerve-damage. Based on FDA recall #Z-1900-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1900-2020%22&limit=1).

The FDA announced on April 1, 2020, that Howmedica Osteonics Corp. voluntarily recalled Cortoss Bone Augmentation Material due to shipments being transported outside required refrigerated temperatures. The agency issued recall number Z-1900-2020 for the Class II device.

How to tell if you have it

  • Brand: Howmedica
  • Product: Cortoss Bone Augmentation Material
  • Catalog Nos.: 2101-0005, 2101-0010
  • Lots (2101-0005): A1907006, A1908003
  • Lots (2101-0010): A1903054, A1906006
  • UDIs: 00808232000962, 00808232000979

The hazard

According to the FDA, potential hazards if used include nerve damage resulting in paralysis and an increased potential for embolism. The record does not report specific incidents or injuries.

Context

GovInfoNow's records show Howmedica Osteonics Corp. has 46 other recalls on record since July 21, 2017. Other recent recalls of similar products include the Biomet Intramedullary Bone Saw Blade Recall (July 1, 2026), the Cerapedics PearMatrix P-15 Bone Graft Recall (Dec. 29, 2025), and the Embosphere 500-700 Micrometer Syringe Recall (Aug. 10, 2026).

How to tell if you have this one

Check the catalog number on the product label: 2101-0005 or 2101-0010. Specific lots for 2101-0005 are A1907006 and A1908003; for 2101-0010, lots A1903054 and A1906006.

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

What to do — step by step

  1. Check Product Details

    Identify the catalog number and lot number on the product label to confirm if it matches the recalled items.

Where it went and when

Where it was distributed

Distributed in 15 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: yesWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: yesVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: yesKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: yesGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “US distribution to California Colorado Florida Georgia Illinois Indiana Kansas Michigan Ohio Pennsylvania Texas Utah Virginia Washington Wisconsin” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Ohio, Pennsylvania, Texas, Utah, Virginia, Washington, Wisconsin.

Recall timeline

FDA terminated this recall 5 months after the firm started it.

1. Firm started the recall: Apr 1, 202012. FDA classified it Class II: May 5, 202023. Published in FDA’s Enforcement Report: May 13, 202034. FDA terminated the recall: Aug 27, 202042020
  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-1900-2020 (April 1, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1900-2020 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