Z-2235-2024Class II

Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog Number: MR2102050...

Name: Z-2235-2024 Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog Number: MR2102050...
Creator: Seaspine Orthopedics Corporation
Published: 2024-05-17
License: https://open.fda.gov/license/

SeaSpine Orthopedics Corporation / initiated 2024-05-17 / Open, Classified / root cause: manufacturing process

FDA source

SEASPINE ORTHOPEDICS CORPORATION began a recall of Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog Number: MR2102050 Product Description: Cranial Caudal Blade... on 2024-05-17. FDA classified it as Class II and gives the reason as "Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2235-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-17
Posted: 2024-06-28
Recalling firm: SeaSpine Orthopedics Corporation
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
Product code: GAD Retractor
Reason for recall: Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
Root cause tag: manufacturing process
FDA 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 in commerce: 31 units
Distribution: United States Nationwide distribution in the states of Nevada, Texas, Michigan, Rhode Island, California, Oregon, Oklahoma, New York, Minnesota.
Product codes and lots: UDI: 10889981300067 Lot Number: WT36299C

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2235-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2234-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-10	2024-06-28
Z-2235-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-10	2024-06-28

Product code GAD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)