Alphatec Spine, Inc.: LIF AMP Adjustable Awl Recalled for Incorrect Assembly and Injury Risk

Agency Publication Date: August 28, 2023

Summary

Alphatec Spine is recalling 29 units of the LIF AMP Adjustable Awl, an instrument used in spinal surgeries. The device's drill button assembly was put together in the wrong direction, which prevents the safety locking feature from working correctly. This defect means surgeons cannot properly control how deep the awl goes, which could lead to accidental over-insertion during a procedure. If you are a patient who has recently undergone a spinal procedure using the AMP System, IdentiTi LIF, Transcend LIF, or Battalion LLIF, contact your surgeon or healthcare provider to discuss any concerns.

Risk

The incorrectly assembled locking mechanism can fail to stop the awl at the intended depth, potentially causing serious internal injuries such as dural tears, damage to blood vessels or nerves, and adjacent tissue damage, which may require revision surgery.

What You Should Do

Check your surgical records or contact your healthcare provider to determine if the LIF AMP Adjustable Awl (REF 117-165) from Lot EM50715 was used in your procedure.
If you are a medical facility, immediately identify and quarantine any units of the LIF AMP Adjustable Awl with UDI-DI 00190376228037 and Lot number EM50715.
Stop using the affected instruments immediately to prevent the risk of surgical complications or patient injury.
Contact Alphatec Spine directly at 1-800-475-8862 or visit their website to arrange for the return and replacement of the defective instruments.
Healthcare providers should monitor patients who may have been treated with these specific instruments for signs of vascular or neurologic injury.
For additional information or to report adverse events, 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 device return

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

Affected Products

Product: LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System

Model / REF:

REF 117-165

UPC Codes:

00190376228037

Lot Numbers:

EM50715

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92776

Status: Active

Manufacturer: Alphatec Spine, Inc.

Sold By: Hospitals; Surgical Centers

Manufactured In: United States

Units Affected: 29

Distributed To: Connecticut, Indiana, Texas, Louisiana, Ohio, Alabama, New Hampshire, Massachusetts, North Carolina, Arizona, Maryland, New Jersey, Illinois, California, Utah, Michigan

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

Check your surgical records or contact your healthcare provider to determine if the LIF AMP Adjustable Awl (REF 117-165) from Lot EM50715 was used in your procedure.

If you are a medical facility, immediately identify and quarantine any units of the LIF AMP Adjustable Awl with UDI-DI 00190376228037 and Lot number EM50715.

Stop using the affected instruments immediately to prevent the risk of surgical complications or patient injury.

Contact Alphatec Spine directly at 1-800-475-8862 or visit their website to arrange for the return and replacement of the defective instruments.

Healthcare providers should monitor patients who may have been treated with these specific instruments for signs of vascular or neurologic injury.

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