Z-1277-2024Class II

D-Clip Standard/Mini Applier, 190mm bayonet, jaw rigid, double action

Name: Z-1277-2024 D-Clip Standard/Mini Applier, 190mm bayonet, jaw rigid, double action
Creator: Peter Lazic Gmbh
Published: 2023-10-06
License: https://open.fda.gov/license/

Peter Lazic GmbH / initiated 2023-10-06 / Open, Classified / root cause: design

FDA source

Peter Lazic Gmbh began a recall of D-Clip Standard/Mini Applier, 190mm bayonet, jaw rigid, double action on 2023-10-06. FDA classified it as Class II and gives the reason as "Customer complaint received that reported the applier failed during surgery. The applier did not release the clip. The applier remained attached to the clip". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1277-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-06
Posted: 2024-03-11
Recalling firm: Peter Lazic GmbH
Product: D-Clip Standard/Mini Applier, 190mm bayonet, jaw rigid, double action.
Product code: HCI Applier, Aneurysm Clip
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.
Root cause tag: design
FDA root cause: 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 ([email protected] +49 (0) 7461 96643 - 20) or Ms. Kim Maier ([email protected] or +49 (0) 7461 96643 - 21).
Quantity in commerce: 26 units
Distribution: US Nationwide distribution in the state of ME.
Product codes and lots: Model number: 35.410; UDI/DI: 04250603739593; All Lot numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1277-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1277-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-20	2024-03-11
Z-1278-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-20	2024-03-11
Z-1279-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-20	2024-03-11

Product code HCI

K180757Class IID-Clip; D-Clip ApplierPeter Lazic GmbH / cleared 2019-04-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)