D-Clip Standard/Mini Applier, 230mm bayonet, jaw rigid, double action.
FDA Recall Z-1279-2024 · Posted 2024-03-11
Recalling FirmPeter Lazic Gmbh
Recall StatusOpen, Classified
Product CodeHCI
Date Initiated2023-10-06
Product Quantity10 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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.