FDA Device recall Z-2405-2021
Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002
- FDA Device
- Class II
- terminated
- Published 2021-09-08
On 2021-09-08 the FDA classified a Class II recall of Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002 by Clarus Medical, citing the sterile barrier seal may be compromised.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2405-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-07-27 |
| Published | 2021-09-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Clarus Medical |
| Distribution | n/a |
Product
Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002
Reason
The sterile barrier seal may be compromised.
Identifiers
| code_info | Model Numbers 1100-002 and 1100-002 SHORT; Serial Numbers 64139 through 65022 |
|---|
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-2405-2021%22
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