Cortoss Bone Augmentation Material 5cc Cartridge — Class II medical device recall Z-2100-2021
Terminated recall by Stryker Spine, reported 2021-07-28, distributed nationwide. The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the dist
| Recall number | Z-2100-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Spine, Allendale, NJ, United States |
| Recall initiated | 2021-05-18 |
| Classified | 2021-07-20 |
| Reported by FDA | 2021-07-28 |
| Terminated | 2022-04-15 |
| Distributed | Nationwide (US) |
| Quantity | 559 total |
| UPC / GTIN / UDI-DI | 00808232000962 |
| Lot numbers | A1908003 |
| Model numbers | 2101-0005 |
Product
Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962
Reason for recall
The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2100-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.