Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Descrip
Summary
The FDA issued a Class II for Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Cat by SEASPINE ORTHOPEDICS CORPORATION. Reason: Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces..
Details
Source
Device Recall
External ID
Z-2357-2024
Action Date
2024-07-24
Status
Ongoing
Category
device
Product Description
Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No
Lot/Code Info: Lot Code: UDI 10889981216368 Lot Numbers TT0190H, TT0191H
Quantity Affected: 100 units
Reason for Recall
Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.
Distribution
The product was distributed to the following US states: Nevada, Colorado, Texas, Washington, Indiana, Georgia, Michigan, Florida, Pennsylvania, Illinois, Tennessee, Virginia, Missouri, South Dakota, California, Montana, Minnesota, Arizona
Type: Voluntary: Firm initiated
Recall Initiated: 2024-06-04
Company
Carlsbad, CA
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 198 device recalls issued in the same week, part of 403 device-related FDA actions this month.
SEASPINE ORTHOPEDICS CORPORATION has 30 FDA actions in our database, including 9 recalls and 21 clearances.
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 (SEASPINE ORTHOPEDICS CORPORATION) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SEASPINE ORTHOPEDICS CORPORATION have FDA actions?
SEASPINE ORTHOPEDICS CORPORATION has 30 FDA actions in our database, including 9 recalls and 21 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2357-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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