FDA-Device2024-07-10Class II
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
SEASPINE ORTHOPEDICS CORPORATION
Hazard
Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
Sold states
United States Nationwide distribution in the states of Nevada, Texas, Michigan, Rhode Island, California, Oregon, Oklahoma, New York, Minnesota.
Affected count
21 units
Manufactured in
5770 Armada Dr, N/A, Carlsbad, CA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2234-2024Don't want to check this manually?
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