Z-2234-2024 Class II Ongoing

Recalled by SEASPINE ORTHOPEDICS CORPORATION — Carlsbad, CA

Recall Details

Product Type
Devices
Report Date
July 10, 2024
Initiation Date
May 17, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
21 units

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

Reason for Recall

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

Distribution Pattern

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

Code Information

UDI: 10889981300050 Lot Number: WT36298C