Recall Z-2758-2026— Paragon 28, Inc.
Class II · Ongoing
Class II FDA medical device recall by Paragon 28, Inc., initiated 2026-06-17. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging..
- Recalling firm
- Paragon 28, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-06-17
- Firm location
- Englewood, CO, United States
Product description
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.
Reason for recall
Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
Data sourced from openFDA. This site is unofficial and independent of the FDA.