FDA recall Z-2235-2024

Product

Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog Number: MR2102050 Product Description: Cranial Caudal Blade Component: Yes, a component of a retractor blade

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.

Key facts

Status

Ongoing

Initiation date

2024-05-17

Report date

2024-07-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Carlsbad, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2235-2024