SEASPINE ORTHOPEDICS CORPORATION: Fathom Pedicle-Based Retractor Blades Recalled for Bone Fracture Risk

Agency Publication Date: June 28, 2024

Summary

SeaSpine Orthopedics Corporation is recalling 52 units of Fathom Pedicle-Based Retractor Cranial Caudal (C/C) Blades because they were manufactured incorrectly. These surgical components, used during spinal procedures, may be defective and can break or cause damage to the patient's bone structure during use. The recall affects two specific sizes of the C/C Blade: the 35-55mm model (21 units) and the 50-80mm model (31 units).

Risk

The incorrectly manufactured blades can fail during surgery, potentially resulting in a fracture of the bone or significant damage to the bone structure where the retractor is being used.

What You Should Do

Identify if you have the affected Fathom Pedicle-Based Retractor C/C Blades by checking the model and lot numbers on your inventory. Affected 35-55mm blades (Model MR2102035) have UDI 10889981300050 and Lot Number WT36298C.
Check for affected 50-80mm blades (Model MR2102050) which have UDI 10889981300067 and Lot Number WT36299C.
Immediately stop using any surgical components identified with these specific lot numbers and quarantine them to prevent further use in medical procedures.
Contact your healthcare provider if you have recently undergone a procedure involving these devices and have concerns about bone health or surgical outcomes.
Contact SeaSpine Orthopedics Corporation at their Carlsbad, California headquarters or through your authorized distributor for instructions on returning the defective blades and obtaining replacements.
For additional information, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer notification and coordination.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Fathom Pedicle-Based Retractor C/C Blade, 35-55mm

Model / REF:

MR2102035

UPC Codes:

10889981300050

Lot Numbers:

WT36298C

Product: Fathom Pedicle-Based Retractor C/C Blade, 50-80mm

Model / REF:

MR2102050

UPC Codes:

10889981300067

Lot Numbers:

WT36299C

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94745

Status: Active

Manufacturer: SEASPINE ORTHOPEDICS CORPORATION

Sold By: Authorized distributors; Direct hospital sales

Manufactured In: United States

Units Affected: 2 products (21 units; 31 units)

Distributed To: Nevada, Texas, Michigan, Rhode Island, California, Oregon, Oklahoma, New York, Minnesota

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if you have the affected Fathom Pedicle-Based Retractor C/C Blades by checking the model and lot numbers on your inventory. Affected 35-55mm blades (Model MR2102035) have UDI 10889981300050 and Lot Number WT36298C.

Check for affected 50-80mm blades (Model MR2102050) which have UDI 10889981300067 and Lot Number WT36299C.

Immediately stop using any surgical components identified with these specific lot numbers and quarantine them to prevent further use in medical procedures.

Contact your healthcare provider if you have recently undergone a procedure involving these devices and have concerns about bone health or surgical outcomes.

Contact SeaSpine Orthopedics Corporation at their Carlsbad, California headquarters or through your authorized distributor for instructions on returning the defective blades and obtaining replacements.

For additional information, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.