Stryker recalls Cortoss Bone Augmentation Material 5cc Cartridges (Catalog 2101-0005) due to potential temperature excursion during distribution. Affected units may not meet refrigeration requirements.
The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution.
Stryker is recalling Cortoss Bone Augmentation Material 5cc Cartridges that may have been exposed to temperatures outside refrigeration during distribution. This could affect the product's safety and effectiveness for medical use.
The product may have been exposed to temperatures outside the required refrigeration range during distribution. This could potentially affect the material's stability and effectiveness for medical use, though the risk of serious harm is not specified in the recall.
Medical professionals using the Cortoss Bone Augmentation Material 5cc Cartridges for spinal procedures are likely affected. Patients receiving this product may be at risk if the material was improperly stored.
Check for the Catalog Number 2101-0005 and GTIN 00808232000962 on the cartridge. Affected units were manufactured in lot A1908003.
Verify the Catalog Number 2101-0005 and GTIN 00808232000962 on the cartridge.
The recall states the product may have been exposed to temperature conditions outside refrigeration, but does not specify that it causes harm if used.
Check for the Catalog Number 2101-0005 and GTIN 00808232000962 on the cartridge. Affected units were manufactured in lot A1908003.
The recall does not provide specific action steps for affected products.
We’ve drafted a message you can send Stryker Spine to request your refund or repair — edit it as you like.
Subject: Recall Z-2100-2021 — Stryker Spine Stryker Spine Hello, I own a Stryker Spine that is covered by recall Z-2100-2021 from Stryker Spine. 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.
