Device 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
Z-2235-2024
Product summary
- Event
- Event 94745
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 31 units
- Official record key
device-enforcement:Z-2235-2024
Official wording
Reason: Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
Code information: UDI: 10889981300067 Lot Number: WT36299C
Distribution pattern: United States Nationwide distribution in the states of Nevada, Texas, Michigan, Rhode Island, California, Oregon, Oklahoma, New York, Minnesota.
Derived failure modes
-
Unknown
Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure