Clarus Medical recalls Lase Discectomy Device Kit models 1100-002 and 1100-002 SHORT with potential sterile barrier seal compromise. Affected units sold between specific serial numbers.
The sterile barrier seal may be compromised.
Clarus Medical is recalling two specific Lase Discectomy Device Kit models due to a possible compromise of the sterile barrier seal. This could lead to infection risks during medical procedures if the device is used without proper sterility.
The sterile barrier seal may become compromised, potentially allowing contamination during medical procedures. This could lead to infection risks if the device is used without proper sterility.
Medical professionals using the recalled device kits are most at risk. Patients undergoing spinal procedures with these kits could face infection risks if the sterile seal is compromised.
Check for model numbers 1100-002 or 1100-002 SHORT on the device kit. Serial numbers 64139 through 65022 indicate affected units.
Verify the model number on the device kit to confirm if it is 1100-002 or 1100-002 SHORT.
Check the serial number to see if it falls within the range 64139 through 65022.
The recall indicates a potential risk of sterile barrier seal compromise, so it is not recommended for use until the recall is addressed.
Check the model number and serial number to see if it is affected; if so, contact Clarus Medical for guidance.
The recall record does not specify a replacement process or remedy.
We’ve drafted a message you can send Clarus Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2405-2021 — Clarus Medical Clarus Medical Hello, I own a Clarus Medical that is covered by recall Z-2405-2021 from Clarus Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
