Class II

Medical Device Recall: 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 bla

SEASPINE ORTHOPEDICS CORPORATION · May 17, 2024

Reason for Recall

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

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

Distribution

United States Nationwide distribution in the states of Nevada, Texas, Michigan, Rhode Island, California, Oregon, Oklahoma, New York, Minnesota.

States Affected

NATIONWIDE

Quantity Affected

21 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2234-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

SEASPINE ORTHOPEDICS CORPORATION Medical Device Recall: 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 bla | SafeCheck