FDA Medical Device Recalls (openFDA)
Clarus Medical, Llc: Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002
- Recall number
- Z-2405-2021
- Recalling firm
- Clarus Medical, Llc
- Product
- Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002
- Status
- Terminated
- Initiated
- 2021-07-27
- Posted
- not on file
- Terminated
- 2022-09-15
- Reason
- The sterile barrier seal may be compromised.
- Root cause
- Packaging process control
- Action
- The affected Domestic customers, Domestic/International Distributors will be notified with a Field Safety Notice. Domestic/International distributors will also include a request for a list of the Distributor s customers.
- Quantity
- 858 units
- Distribution
- Distribution in US - 18 accounts 1 foreign account
- Lot, serial or model codes
- Model Numbers 1100-002 and 1100-002 SHORT; Serial Numbers 64139 through 65022
- 510(k) numbers
- ["K040424","K922881"]
- PMA numbers
- not on file
- Product code
- GEX
- Firm FEI
- 1000116142
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28