FDAFDA · Food and drugs·Recall number Z-2972-2026
Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant
Published August 26, 2026 · Recall initiated: July 10, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Paragon 28, Inc.
- Distributor
- US Nationwide distribution i the state of MT.
- Lot
- Lot Number AOCIA6123
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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