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Open, Classified

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

FDA Recall Z-1278-2024 · Posted 2024-03-11

Recalling FirmPeter Lazic Gmbh
Recall StatusOpen, Classified
Product CodeHCI
Date Initiated2023-10-06
Product Quantity63 units

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.

Firm 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).

Root Cause

Device Design

Distribution Pattern

US Nationwide distribution in the state of ME.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K180757D-Clip; D-Clip ApplierPeter Lazic GmbH · 2019-04-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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