Z-2235-2024 Class II Ongoing
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
- 31 units
Product Description
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 Pattern
United States Nationwide distribution in the states of Nevada, Texas, Michigan, Rhode Island, California, Oregon, Oklahoma, New York, Minnesota.
Code Information
UDI: 10889981300067 Lot Number: WT36299C