Paragon 28, Inc.: Phantom TTC Nails Recalled for Distribution Prior to Sterilization

Agency Publication Date: March 5, 2024

Summary

Paragon 28, Inc. has recalled three units of its Phantom TTC Nail medical devices, which are implants used in orthopedic surgeries. These specific devices were distributed to a healthcare facility in California before the necessary sterilization process was completed. The recall affects three distinct sizes and models identified by individual serial numbers.

Risk

Using a medical device that has not been properly sterilized poses a significant risk of post-operative infection, which can lead to serious health complications or the need for additional surgical procedures. No injuries or infections have been reported to date.

What You Should Do

Identify if you have the affected orthopedic implants by checking the following product names and serial numbers: Phantom TTC Nail 10.0 X 200mm Right (Serial PA23005925), Phantom TTC Nail 10.0 X 150mm Right (Serial PA23005922), or Phantom TTC Nail 11.5 X 250mm Right (Serial PA23006856).
If you are a healthcare provider or facility in possession of these devices, immediately isolate the products and do not use them in any surgical procedures.
If you are a patient who has recently undergone surgery involving a Phantom TTC Nail, contact your surgeon or healthcare provider to confirm if your specific implant was part of this recall.
Contact Paragon 28, Inc. directly at their Englewood, Colorado headquarters for instructions on returning the affected devices and to arrange for a replacement or further assistance.
For additional information, you can contact the FDA's medical device recall line at 1-888-463-6332 or visit the official FDA website at www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer Notification

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

Affected Products

Product: Phantom TTC Nail, 10.0 X 200mm, Right

Lot Numbers:

PA23005925

Product: Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT

Model / REF:

P31-600-175L

Lot Numbers:

PA23005922

Product: Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT

Model / REF:

P31-615-250R

Lot Numbers:

PA23006856

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93900

Status: Active

Manufacturer: Paragon 28, Inc.

Sold By: Healthcare facilities; Hospitals

Manufactured In: United States

Units Affected: 2 products (1)

Distributed To: California

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 orthopedic implants by checking the following product names and serial numbers: Phantom TTC Nail 10.0 X 200mm Right (Serial PA23005925), Phantom TTC Nail 10.0 X 150mm Right (Serial PA23005922), or Phantom TTC Nail 11.5 X 250mm Right (Serial PA23006856).

If you are a healthcare provider or facility in possession of these devices, immediately isolate the products and do not use them in any surgical procedures.

If you are a patient who has recently undergone surgery involving a Phantom TTC Nail, contact your surgeon or healthcare provider to confirm if your specific implant was part of this recall.

Contact Paragon 28, Inc. directly at their Englewood, Colorado headquarters for instructions on returning the affected devices and to arrange for a replacement or further assistance.

For additional information, you can contact the FDA's medical device recall line at 1-888-463-6332 or visit the official FDA website at www.fda.gov/medical-devices/medical-device-recalls.