Stryker Cortoss Bone Augmentation Material 5cc Cartridge Recall: Temperature Risk
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.
Lower-risk recall
The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/62530-stryker-cortoss-bone-augmentation-material-5cc-cartridge-recall-temperature-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/62530-stryker-cortoss-bone-augmentation-material-5cc-cartridge-recall-temperature-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2100-2021
Cite this page
“Stryker Cortoss Bone Augmentation Material 5cc Cartridge Recall: Temperature Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62530-stryker-cortoss-bone-augmentation-material-5cc-cartridge-recall-temperature-risk. Based on FDA recall #Z-2100-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2100-2021%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
Check for the Catalog Number 2101-0005 and GTIN 00808232000962 on the cartridge. Affected units were manufactured in lot A1908003.
- Brand
Stryker Spine- Product
Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
US Nationwide Distribution
| Recall number | Product, codes & lots |
|---|---|
| Z-2100-2021 | Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962; lot A1908003 |
| Z-2101-2021 | Cortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, GTIN 00808232000979; lots A1903054, A1906006 |
What to do — step by step
Check Product Details
Verify the Catalog Number 2101-0005 and GTIN 00808232000962 on the cartridge.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- 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-2100-2021 (May 18, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2100-2021 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.