Stryker Spine: LITe Decompression Snake Arm Recalled for Incorrect Clamp Component

Agency Publication Date: December 21, 2023

Summary

Stryker Spine is recalling 9 units of the LITe Decompression Snake Arm (REF 48080230) because the product arm was manufactured with an incorrect clamp component. This defect prevents the product arm from properly attaching to the arm post shaft during use. Because this issue affects the device's ability to function as intended during medical procedures, the manufacturer has initiated a voluntary recall to address the 9 affected units.

Risk

The incorrect clamp component prevents the snake arm from securely attaching to the support post, which can lead to instability or an inability to use the device during surgical decompression procedures.

What You Should Do

Identify if you have the affected device by checking the product label for LITe Decompression Snake Arm, REF 48080230, and Lot number 227764.
Locate the UDI-DI (GTIN) number 07613327263909 on the device packaging to confirm it is part of this recall.
Immediately stop using the affected product arm and set it aside to prevent use in clinical procedures.
Contact your healthcare provider or Stryker Spine directly to arrange for the return or replacement of the affected product.
For further information or questions regarding 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

Contact manufacturer for instructions

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

Affected Products

Product: LITe Decompression Snake Arm, REF 48080230

Model / REF:

48080230

UPC Codes:

07613327263909

Lot Numbers:

227764

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93573

Status: Active

Manufacturer: Stryker Spine

Sold By: Authorized medical distributors

Manufactured In: United States

Units Affected: 9

Distributed To: Maryland, Michigan, New Mexico, Texas

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 device by checking the product label for LITe Decompression Snake Arm, REF 48080230, and Lot number 227764.

Locate the UDI-DI (GTIN) number 07613327263909 on the device packaging to confirm it is part of this recall.

Immediately stop using the affected product arm and set it aside to prevent use in clinical procedures.

Contact your healthcare provider or Stryker Spine directly to arrange for the return or replacement of the affected product.

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