Howmedica recalls Cortoss Bone Augmentation Material (Catalogs 2101-0005 and 2101-0010) due to potential nerve damage and embolism from improper refrigeration.
Shipments were transported outside of the required refrigerated temperature conditions. Potential hazards if used include nerve damage resulting in paralysis and increased potential for embolism.
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.
The material was shipped outside the required refrigerated temperature conditions. This can cause nerve damage, potentially leading to paralysis, and increases the risk of embolism when used in medical procedures.
Patients who received Cortoss Bone Augmentation Material with the listed catalog numbers and lots are affected. Those undergoing spinal or joint surgery are at higher risk.
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.
Identify the catalog number and lot number on the product label to confirm if it matches the recalled items.
The product is not safe to use as shipped without proper refrigeration. It may cause nerve damage or embolism.
The recall does not specify a remedy, so contact Howmedica Osteonics Corp. for guidance.
Look for catalog numbers 2101-0005 or 2101-0010 with specific lots: A1907006, A1908003 for 2101-0005; A1903054, A1906006 for 2101-0010.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-1900-2020 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-1900-2020 from Howmedica. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
