Class II

Medical Device Recall: P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number P31-955-1800-S; provides stabilization of the hindfoot and ankle.

Paragon 28, Inc. · June 17, 2026

Reason for Recall

Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.

Distribution

US nationwide, Australia, Canada, The Netherlands, and New Zealand

States Affected

NATIONWIDE

Quantity Affected

514 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2758-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.