D-Clip Standard/Mini Applier, 230mm bayonet, jaw rigid, double action.
FDA device recall Z-1279-2024 · posted 2024-03-11 · Open, Classified
Recall details
- Recalling firm
- Peter Lazic Gmbh
- 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.
- 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).
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- HCI
- Quantity affected
- 10 units
- Distribution
- US Nationwide distribution in the state of ME.
- Date initiated
- 2023-10-06
- Date posted
- 2024-03-11
- Location
- Tuttlingen, Germany
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| D-Clip; D-Clip Applier (K180757) | Peter Lazic GmbH | 2019-04-12 |