Fathom Pedicle Retractor Blades Recalled for Manufacturing Defect
SeaSpine Orthopedics recalls Fathom Pedicle-Based Retractor C/C Blades due to manufacturing defects that could cause bone fracture or damage during surgery. 21 units were distributed nationwide.
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: FDA Class II medical device with a manufacturing defect in a surgical instrument that poses a risk of bone fracture or damage during use. Although no illnesses or injuries have been reported, the potential for serious harm during surgical procedures qualifies this as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
SeaSpine Orthopedics Corporation is recalling Fathom Pedicle-Based Retractor C/C Blades (model MR2102035, lot WT36298C) due to manufacturing defects in the product.
The affected blades were manufactured incorrectly and could fracture or damage bone structures if used during spinal surgery. This defect poses a risk of injury to patients during surgical procedures.
The recall affects 21 units that were distributed nationwide to healthcare facilities in Nevada, Texas, Michigan, Rhode Island, California, Oregon, Oklahoma, New York, and Minnesota.
Healthcare providers using these devices should discontinue use immediately and contact SeaSpine Orthopedics or the FDA for instructions on device return or replacement.
The recalled product
- Product
- Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm Model/Catalog Number: MR2102035 Product Description: Cranial Caudal Blade Component: Yes, a component of a retractor blade
- Manufacturer
- SEASPINE ORTHOPEDICS CORPORATION
- Affected units
- 21
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: 10889981300050 Lot Number: WT36298C
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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