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U.S. Department of Health and Human Services

Class 2 Device Recall DClip Applier, Product 35.412

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  Class 2 Device Recall DClip Applier, Product 35.412 see related information
Date Initiated by Firm October 06, 2023
Date Posted March 11, 2024
Recall Status1 Open3, Classified
Recall Number Z-1279-2024
Recall Event ID 93938
510(K)Number K180757  
Product Classification Applier, aneurysm clip - Product Code HCI
Product D-Clip Standard/Mini Applier, 230mm bayonet, jaw rigid, double action.
Code Information Model number: 35.412; UDI/DI: 04250603739616; All Lot numbers.
Recalling Firm/
Manufacturer		 Peter Lazic Gmbh
Immelmannweg 2
Tuttlingen Germany
For Additional Information Contact Peter Lazic US Inc.
7461 96643 20
Manufacturer Reason
for Recall		 Customer complaint received that reported the applier failed during surgery. The applier did not release the clip. The applier remained attached to the clip.
FDA Determined
Cause 2		 Device Design
Action Reportable Event - Removal letters dated October 6, 2023 were sent to customers. Customers were instructed to return all product subject to recall and to notify any of their customers as well. Please return items for the attention of one of the PRRCs provided to ensure quick processing and assignment to the case. If you have any questions, please contact Mr. Sven Lazic (info@lazic.de +49 (0) 7461 96643 - 20) or Ms. Kim Maier (k.maier@lazic.de or +49 (0) 7461 96643 - 21).
Quantity in Commerce 10 units
Distribution US Nationwide distribution in the state of ME.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = HCI and Original Applicant = Peter Lazic GmbH
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