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FDA Medical Device Recalls (openFDA)

Peter Lazic Gmbh: D-Clip Standard/Mini Applier, 230mm bayonet, jaw rigid, double action.

Recall number
Z-1279-2024
Recalling firm
Peter Lazic Gmbh
Product
D-Clip Standard/Mini Applier, 230mm bayonet, jaw rigid, double action.
Status
Open, Classified
Initiated
2023-10-06
Posted
2024-03-11
Terminated
not on file
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.
Root cause
Device Design
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 (info@lazic.de +49 (0) 7461 96643 - 20) or Ms. Kim Maier (k.maier@lazic.de or +49 (0) 7461 96643 - 21).
Quantity
10 units
Distribution
US Nationwide distribution in the state of ME.
Lot, serial or model codes
Model number: 35.412; UDI/DI: 04250603739616; All Lot numbers.
510(k) numbers
["K180757"]
PMA numbers
not on file
Product code
HCI
Firm FEI
3007264034
Firm city
Tuttlingen
Firm state
not on file
Firm country
Germany

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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