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.
What this means for you
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
- fracture
- bone-damage
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
Distributed nationwide across the United States.
Related recalls
Same category
- HighPhilips Azurion X-Ray Systems Table Movement Control Defect Recall
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula cardiopulmonary bypass catheter
FDA (Devices) · 2026-05-27
- HighTangent Single Use Digital Catheter Recalled for Distal Shaft Fractures
FDA (Devices) · 2026-05-27