SEASPINE ORTHOPEDICS CORPORATION: Device Recall
Recall #Z-2234-2024 · 05/17/2024
Class II: Risk
Recall Details
- Recall Number
- Z-2234-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- SEASPINE ORTHOPEDICS CORPORATION
- Status
- Ongoing
- Date Initiated
- 05/17/2024
- Location
- Carlsbad, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21 units
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 Pattern
United States Nationwide distribution in the states of Nevada, Texas, Michigan, Rhode Island, California, Oregon, Oklahoma, New York, Minnesota.
Other Recalls by SEASPINE ORTHOPEDICS CORPORATION
- Class II: Risk 11/17/2025
- Class II: Risk 08/06/2025
- Class II: Risk 10/29/2024
- Class II: Risk 10/29/2024
- Class II: Risk 06/04/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.