Recall Z-1278-2024— Peter Lazic Gmbh
Class II · Ongoing
Class II FDA medical device recall by Peter Lazic Gmbh, initiated 2023-10-06. It names one FDA 510(k) clearance: K180757. Product: D-Clip Standard/Mini Applier, 210mm bayonet, jaw rigid, double action.. Reason: Customer complaint received that reported the applier failed during surgery. The applier did not release the clip. The applier remained attached to the clip..
- Recalling firm
- Peter Lazic Gmbh
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-10-06
- Firm location
- Tuttlingen, N/A, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
D-Clip Standard/Mini Applier, 210mm bayonet, jaw rigid, double action.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.