Class 2 Device Recall Lase

• Date Initiated by Firm: July 27, 2021
• Create Date: September 03, 2021
• Recall Status: Terminated 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
• FEI Number: 1000116142
• 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: 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; 510(K)s with Product Code = GEX