United StatesP28 PHANTON INTRAMEDULLARY NAIL SYSTEM — Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, size 0.30 mm, length 800 mm, item number P31-955-1800-S — identified by UDIs and lot numbers (Lot 501167202225, 501167302225, 501209514725, 501259627925, 501275832225 and corresponding UDIs). The product was recalled after Paragon 28 received two complaints of breaches in the sterile barrier of the pouch packaging.
What's being recalled
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.
Recalling firm: Paragon 28, Inc., Englewood, CO, United States.
How to identify it
UDI (01)00889795061577(17)300122(10)501167202225, Lot Number 501167202225; UDI (01)00889795061577(17)300122(10)501167302225, Lot Number 501167302225; UDI (01)00889795061577(17)300527(10)501209514725, Lot Number 501209514725; UDI (01)00889795061577(17)301006(10)501259627925, Lot Number 501259627925; UDI (01)00889795061577(17)301118(10)501275832225, Lot Number 501275832225.
The hazard
Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US nationwide, Australia, Canada, The Netherlands, and New Zealand
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada