Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm Model/Catalog Number: MR2102035 Product D
Summary
The FDA issued a Class II for Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm Mo by SEASPINE ORTHOPEDICS CORPORATION. Reason: Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure.
Details
Source
Device Recall
External ID
Z-2234-2024
Action Date
2024-07-10
Status
Ongoing
Category
device
Product Description
Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm Model/Catalog Number: MR2102035 Product Description: Cranial Caudal Blade Component: Yes, a component of a retractor blade
Lot/Code Info: UDI: 10889981300050 Lot Number: WT36298C
Quantity Affected: 21 units
Reason for Recall
Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
Distribution
United States Nationwide distribution in the states of Nevada, Texas, Michigan, Rhode Island, California, Oregon, Oklahoma, New York, Minnesota.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-17
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 147 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-2234-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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