D-Clip Standard/Mini Applier, 230mm bayonet, jaw rigid, double action.
Summary
The FDA issued a Class II for D-Clip Standard/Mini Applier, 230mm bayonet, jaw rigid, double action. by Peter Lazic Gmbh. Reason: Customer complaint received that reported the applier failed during surgery. The applier did not release the clip. The applier remained attached to th.
Details
Source
Device Recall
External ID
Z-1279-2024
Action Date
2024-03-20
Status
Ongoing
Category
device
Product Description
D-Clip Standard/Mini Applier, 230mm bayonet, jaw rigid, double action.
Lot/Code Info: Model number: 35.412; UDI/DI: 04250603739616; All Lot numbers.
Quantity Affected: 10 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.
Distribution
US Nationwide distribution in the state of ME.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-06
Company
Tuttlingen, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 148 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Peter Lazic Gmbh has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Peter Lazic Gmbh) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Peter Lazic Gmbh have FDA actions?
Peter Lazic Gmbh has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1279-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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