D-Clip Standard/Mini Applier, 230mm bayonet, jaw rigid… recallZ-1279-2024 · Peter Lazic Gmbh · initiated Oct 6, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Peter Lazic Gmbh or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Device Design
What the company is doing
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 ([email protected] +49 (0) 7461 96643 - 20) or Ms. Kim Maier ([email protected] or +49 (0) 7461 96643 - 21).
Recall details
- Recall number
- Z-1279-2024
- Status
- Open, Classified
- Initiated by the company
- Oct 6, 2023
- Posted by the FDA
- Mar 11, 2024
- Recalling firm
- Peter Lazic Gmbh
- Quantity
- 10 units
- Product code
- HCI
- FDA submissions
- K180757
- Distribution
- US Nationwide distribution in the state of ME.
Product description
D-Clip Standard/Mini Applier, 230mm bayonet, jaw rigid, double action.
Code information (models, lots, serial numbers)
Model number: 35.412; UDI/DI: 04250603739616; All Lot numbers.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- LAZIC 35.412Peter Lazic GmbH · Applier, Aneurysm Clip1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 93938).
- Z-1277-2024 · Open, ClassifiedD-Clip Standard/Mini Applier, 190mm bayonet, jaw rigid, double action.
- Z-1278-2024 · Open, ClassifiedD-Clip Standard/Mini Applier, 210mm bayonet, jaw rigid, double action.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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