CLASS II ONGOING Device recall · Reported 20 Mar 2024 · FDA Enforcement Report

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

Peter Lazic is recalling D-Clip Standard/Mini Applier bayonet, jaw rigid, double action, distributed nationwide in the US. The recall was initiated on 6 Oct 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel number: 35.411; UDI/DI: 04250603739609; All Lot numbers.
Quantity recalled63 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1278-2024
FDA event ID
93938
Recalling firm
Peter Lazic, Tuttlingen, N/A
Classification
Class II
Status
Ongoing
Recall initiated
6 Oct 2023
FDA classified
11 Mar 2024
Reported
20 Mar 2024
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

6 Oct 2023Recall initiated by company
11 Mar 2024Classified by FDA+157 days
20 Mar 2024Published in enforcement report+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

D-Clip Standard/Mini Applier, 210mm bayonet, jaw rigid, double action.

Where it was distributed

US Nationwide distribution in the state of ME.

Nationwide

Questions about this recall

Is D-Clip Standard/Mini Applier bayonet, jaw rigid, double action recalled?

Yes. Peter Lazic recalled D-Clip Standard/Mini Applier bayonet, jaw rigid, double action on 6 Oct 2023. The recall is Class II and its status is Ongoing. Recall number Z-1278-2024.

Why was it 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.

Which lots are affected?

Model number: 35.411; UDI/DI: 04250603739609; All Lot numbers.

Where was it sold?

US Nationwide distribution in the state of ME.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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