Intrinsic Therapeutics, Inc.: Barricaid Annular Closure Impactor Recalled for Missing Welds

Agency Publication Date: August 20, 2024

Summary

Intrinsic Therapeutics is recalling 207 units of the Barricaid Annular Closure Impactor because at least two units were found to be missing a required weld. This surgical device is used during spinal procedures, and a missing weld could cause the instrument to fail or break during surgery. Affected units include specific lot numbers of model REF: BAR-IMPACTOR, P/N: 400906-A, which were distributed nationwide across the United States.

Risk

A missing weld on the surgical impactor may lead to structural failure of the device during a procedure, potentially causing surgical delays or leaving metal fragments in the patient.

What You Should Do

Check your surgical inventory for the Barricaid Annular Closure Impactor with Model REF: BAR-IMPACTOR or P/N: 400906-A.
Identify if your device belongs to one of the following affected lot numbers: 10282203, 06152307, 08292301, or 10112307.
Immediately stop using any impacted devices and quarantine them to prevent use in surgical procedures.
Contact your healthcare provider or Intrinsic Therapeutics directly to discuss the return of affected units and to arrange for replacements or further instructions.
For additional questions or to report issues, 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 Management

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

Affected Products

Product: Barricaid Annular Closure Impactor

Model / REF:

REF: BAR-IMPACTOR

P/N: 400906-A

UDI-DI: M906IMP1A0

Lot Numbers:

10282203

06152307

08292301

10112307

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95066

Status: Active

Manufacturer: Intrinsic Therapeutics, Inc.

Manufactured In: United States

Units Affected: 207 units

Distributed To: Nationwide

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 inventory for the Barricaid Annular Closure Impactor with Model REF: BAR-IMPACTOR or P/N: 400906-A.

Identify if your device belongs to one of the following affected lot numbers: 10282203, 06152307, 08292301, or 10112307.

Immediately stop using any impacted devices and quarantine them to prevent use in surgical procedures.

Contact your healthcare provider or Intrinsic Therapeutics directly to discuss the return of affected units and to arrange for replacements or further instructions.

For additional questions or to report issues, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.