Discectomy Device Kit Class II recall due to sterile barrier compromise
Clarus Medical recalls the Lase Discectomy Device Kit due to potential compromise of the sterile barrier seal. Approximately 858 units were distributed in the US and internationally.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall where the hazard—potential sterile barrier compromise—is theoretical and no illnesses or injuries have been reported. However, this presents a risk-of-harm scenario for a surgical device, as compromised sterility during surgery could lead to serious infection.
Plain-English summary
Clarus Medical is recalling the Lase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORT (Serial Numbers 64139 through 65022), due to a potential compromise in the sterile barrier seal. Approximately 858 units have been distributed to 18 accounts in the United States and 1 account internationally.
The sterile barrier seal is designed to maintain the sterility of the surgical instruments before use. If compromised, the device may not remain sterile, potentially exposing patients to contamination during surgery.
No illnesses or injuries related to this issue have been reported. Healthcare providers should cease use of affected devices and contact Clarus Medical for instructions on returning the units.
The recalled product
- Product
- Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002
- Manufacturer
- Clarus Medical, Llc
- Category
- Medical Device — Surgical
- Hazard
- sterility-compromise
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model Numbers 1100-002 and 1100-002 SHORT
- Serial Numbers 64139 through 65022
Distribution
Distribution scope not specified by the agency.
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