FDAClass IIJuly 10, 2024

Brand Name: Fathom Pedicle-Based Retractor Product recall

Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog Number: MR2102050 Product Description: Cranial Caudal Blade…

Why was Brand Name: Fathom Pedicle-Based Retractor Product recalled?

Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI: 10889981300067 Lot Number: WT36299C

Product
Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog Number: MR2102050 Product Description: Cranial Caudal Blade…
Recalling firm
SEASPINE ORTHOPEDICS CORPORATION
Quantity
31 units
Distribution
United States Nationwide distribution in the states of Nevada, Texas, Michigan, Rhode Island, California, Oregon, Oklahoma, New York, Minnesota.
Recall date
July 10, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls