United StatesParagon 28 is recalling the Phantom Fibula Nail, 2.8 mm x 130 mm, Right, Ti, REF P36-128-130R-S (Lot 501182207125, UDI‑DI 00889795133670, expiration March 13, 2030) distributed nationwide in NJ, WA, NY, MD, CA, FL, NM, TX, IL, OH, NV, TN, LA. The nail has out-of-specification thread depths that may prevent the implant from mating properly with the associated mounting bolt, which could require the surgery to be aborted.
What's being recalled
Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
Recalling firm: Paragon 28, Inc., Englewood, CO, United States.
How to identify it
UDI-DI: 00889795133670. Lot: 501182207125. Expiration: March 13th, 2030
The hazard
Fibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of specification thread depths on the fibula nail, so implant may not be able to mate properly with the associated mounting bolt. If nail (implant) cannot properly mate with instrumentation, the surgery potentially will need to be aborted.
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 distribution in the states of NJ, WA, NY, MD, CA, FL, NM, TX, IL, OH, NV, TN, LA.
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