The Recall Desk
HighFDA (Devices)·Z-1254-2024·Announced 2024-03-13

Paragon 28 Phantom TTC Nail distributed prior to sterilization

Paragon 28 is recalling Phantom TTC Nails distributed before sterilization. Non-sterile surgical devices pose a potential infection risk if implanted.

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: FDA Class II recall of a non-sterile surgical implant device. Although no illnesses or injuries have been reported, non-sterile surgical nails represent a risk-of-harm product where infection is a theoretical but significant threat if implanted.

Plain-English summary

Paragon 28, Inc. is recalling Phantom TTC Nails (10.0 X 200mm, Right) with lot code PA23005925 that were distributed prior to sterilization. Non-sterile medical devices pose a potential infection risk, particularly for implantable surgical products. Medical devices must be properly sterilized before distribution to patients.

The recalled nails were distributed in California. Patients and healthcare providers who may have received this product should consult with their healthcare provider regarding potential exposure to non-sterile devices.

The recalled product

Product
Phantom TTC Nail, 10.0 X 200mm, Right
Manufacturer
Paragon 28, Inc.
Category
Medical Device — Surgical implant
Hazard
  • non-sterile
  • infection-risk
  • sterilization-failure

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)

  • PA23005925

Distribution

Distributed in 1 state:

  • CA

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