# FDA recall Z-2235-2024

> **SEASPINE ORTHOPEDICS CORPORATION** · Class II · device recall initiated 2024-05-17.

## 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

- **Recall number:** Z-2235-2024
- **Recalling firm:** SEASPINE ORTHOPEDICS CORPORATION
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-05-17
- **Report date:** 2024-07-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Carlsbad, CA, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-2235-2024. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/Z-2235-2024. Source: US FDA. Licensed CC0.

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