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FDA · Medical devices ·

Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant recall

Paragon 28, Inc. recalled Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant on August 26, 2026 because of device was recalled due to an elevated oxygen level in excess of the allowable limit. It was sold nationwide.

Why it was recalled

Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.

What's recalled

Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant

Quantity: 1 unit

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Paragon 28, Inc., Englewood, CO
Date
Severity
Class III
the product is unlikely to cause health problems but breaks a rule.
Where sold
Nationwide
US Nationwide distribution i the state of MT.
Status
Ongoing
Recall number
Z-2972-2026
Source
U.S. Food and Drug Administration

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