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Recall Observatory FDA recall evidence

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

May 17, 2024

Class II

Product summary

Firm
SEASPINE ORTHOPEDICS CORPORATION
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

    reason.no_named_rule · v1.0.0

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