FDA Medical Device Recalls (openFDA)
SEASPINE ORTHOPEDICS CORPORATION: 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
- Recall number
- Z-2234-2024
- Recalling firm
- SEASPINE ORTHOPEDICS CORPORATION
- 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
- Status
- Open, Classified
- Initiated
- 2024-05-17
- Posted
- 2024-06-28
- Terminated
- not on file
- Reason
- Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 21 units
- Distribution
- United States Nationwide distribution in the states of Nevada, Texas, Michigan, Rhode Island, California, Oregon, Oklahoma, New York, Minnesota.
- Lot, serial or model codes
- UDI: 10889981300050 Lot Number: WT36298C
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GAD
- Firm FEI
- 3012120772
- Firm city
- Carlsbad
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28