D-Clip Standard/Mini Applier, 230mm bayonet, jaw rigid, double action.
This recall is currently active, issued March 11, 2024. It was issued by Peter Lazic Gmbh Immelmannweg 2 Tuttlingen Germany.
- Recall Initiated
- October 6, 2023
- Posted
- March 11, 2024
- Recall Number
- Z-1279-2024
- Quantity
- 10 units
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide distribution in the state of ME.
Lot / Code Info
Model number: 35.412; UDI/DI: 04250603739616; All Lot numbers.
Root Cause
Device Design
Action Taken
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 (info@lazic.de +49 (0) 7461 96643 - 20) or Ms. Kim Maier (k.maier@lazic.de or +49 (0) 7461 96643 - 21).