FDA Device recall Z-1026-2022
Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage
- FDA Device
- Class II
- terminated
- Published 2022-05-11
On 2022-05-11 the FDA classified a Class II recall of Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage by Restor3d, citing product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1026-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-03-30 |
| Published | 2022-05-11 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Restor3d |
| Distribution | US |
Product
Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual surgical instrument
Reason
Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium.
Identifiers
| code_info | Model: 6110-N01-KTS01 Lot: 2022030005 UDI: 00840097504506 |
|---|
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-1026-2022%22
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