FDA Device recall Z-2100-2021
Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962
- FDA Device
- Class II
- terminated
- Published 2021-07-28
On 2021-07-28 the FDA classified a Class II recall of Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962 by Stryker Spine, citing the products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2100-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-05-18 |
| Published | 2021-07-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Stryker Spine |
| Distribution | US |
Product
Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962
Reason
The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution.
Identifiers
| code_info | lot A1908003 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2100-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.