Stryker recalls Cortoss Bone Augmentation Material 10cc Cartridges (Catalog 2101-0010) due to potential temperature excursion during distribution. Affected lots A1903054 and A1906006 may have been stored outside refrigeration for up to 12 hours.
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 10cc Cartridges that may have been exposed to temperatures outside the required refrigeration range for up to 12 hours during distribution. This could potentially affect the product's safety and effectiveness for medical use.
The recalled cartridges may have been stored outside the required refrigeration conditions for up to 12 hours during distribution. This temperature excursion could potentially affect the product's stability and effectiveness for medical use, though the exact impact is not specified.
Medical professionals using Cortoss Bone Augmentation Material 10cc Cartridges with catalog number 2101-0010 and GTIN 00808232000979 are most at risk. Patients receiving these products may need to verify if their cartridges were affected.
Check for the catalog number 2101-0010 and GTIN 00808232000979 on the cartridge. Affected lots are A1903054 and A1906006.
Look for the catalog number 2101-0010 and GTIN 00808232000979 on the cartridge.
Stryker recalls these cartridges because they may have experienced a 12-hour temperature excursion outside the required refrigeration conditions during distribution.
Check the catalog number and GTIN on the cartridge. If it matches 2101-0010 and GTIN 00808232000979, and the lot number is A1903054 or A1906006, you should contact Stryker Spine for further instructions.
The recall is due to potential temperature issues that could affect the product's effectiveness, but no specific injury risk is mentioned in the official notice.
We’ve drafted a message you can send Stryker Spine to request your refund or repair — edit it as you like.
Subject: Recall Z-2101-2021 — Stryker Spine Stryker Spine Hello, I own a Stryker Spine that is covered by recall Z-2101-2021 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.
