FDA recall Z-2758-2026

Paragon 28, Inc. · Class II · device

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 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

Key facts

Status
Ongoing
Initiation date
2026-06-17
Report date
2026-07-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Englewood, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2758-2026