Fathom recallZ-2235-2024 · Seaspine Orthopedics Corporation · initiated May 17, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Seaspine Orthopedics Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
FDA root cause category: Under Investigation by firm
What the company is doing
On May 17, 2024, SeaSpine Orthopedics Corporation issued a "Urgent: Medical Device Recall" notification. via E-Mail (DocuSign) to affected consignees. 1. Please return the entire Fathom set to SeaSpine s Carlsbad facility for evaluation and potential rework of the affected blades. A shipping label is attached for your convenience. 2. To support your upcoming cases, please continue to utilize the loaner pool. Upon receipt of the affected inventory, it will take approximately three weeks for rework and return to the loaner pool. 3. Once the inventory has been returned, please acknowledge via DocuSign.
Recall details
- Recall number
- Z-2235-2024
- Status
- Open, Classified
- Initiated by the company
- May 17, 2024
- Posted by the FDA
- Jun 28, 2024
- Recalling firm
- Seaspine Orthopedics Corporation
- Quantity
- 31 units
- Product code
- GAD
- Distribution
- United States Nationwide distribution in the states of Nevada, Texas, Michigan, Rhode Island, California, Oregon, Oklahoma, New York, Minnesota.
Product description
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
Code information (models, lots, serial numbers)
UDI: 10889981300067 Lot Number: WT36299C
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Fathom MR2-102050Seaspine Orthopedics Corporation · RETRACTOR1 recall1 report
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 94745).
- Z-2234-2024 · Open, ClassifiedBrand 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…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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