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U.S. Department of Health and Human Services

Class 2 Device Recall Lase

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  Class 2 Device Recall Lase see related information
Date Initiated by Firm July 27, 2021
Create Date September 03, 2021
Recall Status1 Terminated 3 on September 15, 2022
Recall Number Z-2405-2021
Recall Event ID 88399
510(K)Number K040424  K922881  
Product Classification Powered laser surgical instrument - Product Code GEX
Product Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002
Code Information Model Numbers 1100-002 and 1100-002 SHORT; Serial Numbers 64139 through 65022
Recalling Firm/
Manufacturer		 Clarus Medical, Llc
13355 10th Ave N Ste 110
Minneapolis MN 55441-5554
For Additional Information Contact Mark F. Brown
763-525-8400
Manufacturer Reason
for Recall		 The sterile barrier seal may be compromised.
FDA Determined
Cause 2		 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 in Commerce 858 units
Distribution Distribution in US - 18 accounts 1 foreign account
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEX and Original Applicant = CLARUS MEDICAL SYSTEMS, INC.
510(K)s with Product Code = GEX and Original Applicant = CLARUS MEDICAL, LLC.
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