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.
- Hazard
- unsterilized-device
- infection-risk
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:
- CA
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