SEASPINE ORTHOPEDICS CORPORATION: Meridian Angled Awl Fixed Recalled for Risk of Breakage During Surgery

Agency Publication Date: July 15, 2024

Summary

SeaSpine Orthopedics Corporation is recalling 100 units of the Meridian Angled Awl Fixed, a surgical instrument used in orthopedic procedures. The recall was initiated because the weld around the instrument's cap component is insufficient to withstand the forces applied during surgical impaction, which could cause the device to fail or break while in use. These devices were distributed to healthcare facilities in 18 states, including California, Texas, and Florida. Contact your healthcare provider or the manufacturer for further instructions regarding this equipment.

Risk

The insufficient weld may fail when the instrument is struck during surgery, potentially causing the device to break or fragments to enter the patient's surgical site, leading to procedural delays or injury.

What You Should Do

Identify affected Meridian Angled Awl Fixed surgical awls by checking the Model/Catalog Number RA2-003015.
Verify the specific lot information on the product packaging: look for UDI 10889981216368 with Lot Numbers TT0190H or TT0191H.
Healthcare facilities should immediately stop using these specific lots and quarantine any remaining inventory.
Contact SeaSpine Orthopedics Corporation at their Carlsbad, California headquarters or your local representative to coordinate the return and replacement of affected instruments.
Consult with your surgical team or healthcare provider if this instrument was used during a recent procedure to discuss any potential concerns.
For further questions about this recall, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer Notification and Device Return

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

Affected Products

Product: Meridian Angled Awl Fixed (Surgical Awl)

Model / REF:

RA2-003015

Lot Numbers:

UDI 10889981216368 Lot Numbers TT0190H, TT0191H

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94872

Status: Active

Manufacturer: SEASPINE ORTHOPEDICS CORPORATION

Sold By: Hospitals and surgical centers

Manufactured In: United States

Units Affected: 100 units

Distributed To: Nevada, Colorado, Texas, Washington, Indiana, Georgia, Michigan, Florida, Pennsylvania, Illinois, Tennessee, Virginia, Missouri, South Dakota, California, Montana, Minnesota, Arizona

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 affected Meridian Angled Awl Fixed surgical awls by checking the Model/Catalog Number RA2-003015.

Verify the specific lot information on the product packaging: look for UDI 10889981216368 with Lot Numbers TT0190H or TT0191H.

Healthcare facilities should immediately stop using these specific lots and quarantine any remaining inventory.

Contact SeaSpine Orthopedics Corporation at their Carlsbad, California headquarters or your local representative to coordinate the return and replacement of affected instruments.

Consult with your surgical team or healthcare provider if this instrument was used during a recent procedure to discuss any potential concerns.

For further questions about this recall, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.