Surgical retractor blade manufacturing defect could cause bone fracture
SeaSpine Orthopedics is recalling Fathom Pedicle-Based Retractor C/C Blades due to manufacturing defects that could cause bone fracture. The recall affects 31 units distributed across nine US states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a surgical device where manufacturing defects could result in bone fracture or damage. The source text does not report actual injuries; the risk is theoretical based on manufacturing concerns. Per the severity rubric, risk-of-harm products without reported injury receive a score of 3 (High).
Plain-English summary
SeaSpine Orthopedics Corporation is recalling Fathom Pedicle-Based Retractor C/C Blades (Model MR2102050) due to manufacturing defects. The Cranial Caudal Blade component could fracture or damage bone structure during use in spinal surgery.
The recall affects 31 units with Lot Number WT36299C distributed to healthcare facilities in Nevada, Texas, Michigan, Rhode Island, California, Oregon, Oklahoma, New York, and Minnesota.
Affected healthcare facilities should immediately discontinue use and contact SeaSpine Orthopedics Corporation for guidance on product return or replacement.
The recalled product
- 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
- Manufacturer
- SEASPINE ORTHOPEDICS CORPORATION
- Hazard
- Affected units
- 31
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 10889981300067 Lot Number: WT36299C
Distribution
Part of a larger recall action
This product is one of 2 recalled by SEASPINE ORTHOPEDICS CORPORATION under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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