The Recall Desk
HighFDA (Devices)·Z-1255-2024·Announced 2024-03-13

Paragon 28 Phantom TTC Nail recalled for unsterilized distribution

Paragon 28, Inc. is recalling the Phantom TTC Nail (10.0 X 150mm, RIGHT) distributed in California, as these devices were shipped prior to sterilization. Unsterilized surgical implants pose a serious risk of infection and complications.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for unsterilized surgical devices distributed in California. Although no illnesses or injuries have been reported, unsterilized surgical implants pose a documented risk of serious infection and post-operative complications, meeting the criterion for High severity.

Plain-English summary

The Phantom TTC Nail, a surgical orthopedic device manufactured by Paragon 28, Inc., is being recalled due to distribution prior to sterilization. The affected product is the 10.0 X 150mm RIGHT model (REF: P31-600-175L, code PA23005922), distributed in California.

Surgical implants must be sterile to prevent life-threatening infections and complications. Unsterilized nails could introduce bacteria or other pathogens into the surgical site, potentially causing serious infections, delayed healing, or other post-operative complications.

The recall affects patients who received this specific device during orthopedic procedures. Patients who received this product should contact their healthcare provider immediately to discuss the risk and determine whether they need evaluation or removal of the device.

Paragon 28, Inc. initiated this recall. Healthcare providers and patients in California who have or know they received this device should discontinue use if not yet implanted and consult with their surgeon regarding management options.

The recalled product

Product
Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L
Manufacturer
Paragon 28, Inc.
Category
Medical Device — Orthopedic Surgical Implant
Hazard
Affected units
1

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • PA23005922

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 3 recalled by Paragon 28, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Paragon 28, Inc.

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Same hazard · unsterilized device

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