FDAClass IIIAugust 26, 2026

Custom Made Device Implant 6123 Navicular Cage Small recall

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

Why was Custom Made Device Implant 6123 Navicular Cage Small 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 should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number AOCIA6123

Product
Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant
Recalling firm
Paragon 28, Inc.
Quantity
1
Distribution
US Nationwide distribution i the state of MT.
Recall date
August 26, 2026
Classification
Class III
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls