Paragon 28 recall: Custom Made Device Implant 6123 Navicular Cage Small Right Rev A and 1 more product
Paragon 28, Inc. is recalling Custom Made Device Implant 6123 Navicular Cage Small Right Rev A and 1 more product – 1; 1 unit. The U.S. Food and Drug Administration published the recall on August 26, 2026; it began on July 10, 2026. Distributed nationwide.
Lower risk Class III means using the product is not likely to cause health problems; it breaks a labeling or manufacturing rule.
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| Product | Custom Made Device Implant 6123 Navicular Cage Small Right Rev A and 1 more product |
| Brand | Paragon 28 |
| Company | Paragon 28, Inc. |
| Type | Medical devices |
| Classification | Class III |
| Recall date | July 10, 2026 |
| Published by FDA | August 26, 2026 |
| Quantity | 1; 1 unit |
| Recall ID | 99504 |
Recalled products (2)
- Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant
- FDA recall number
- Z-2971-2026
- Codes, lots and dates
- Lot Number AOCIA6123
- Quantity
- 1
- Classification
- Class III
- Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant
- FDA recall number
- Z-2972-2026
- Codes, lots and dates
- Lot Number AOCIA6123
- Quantity
- 1 unit
- Classification
- Class III
Identifiers and details
- FDA event ID
- 99504
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Englewood, CO, United States
Why it was recalled
The reason the FDA lists: “Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.”
Where it was sold
Nationwide. Distribution as the FDA records it: “US Nationwide distribution i the state of MT.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99504, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
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| Oct 7, 2026 | Siemens Healthcare Diagnostics recall: Atellica CH Revised C-Reactive ProteinMedical devices · 42940 units (3938 US, 39002 OUS) | The potential for falsely elevated results. Serious | FDA Class II |
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About this recall
Is Paragon 28 Custom Made Device Implant 6123 Navicular Cage Small Right Rev A recalled?
Yes. Paragon 28, Inc. recalled it on July 10, 2026; FDA published it August 26, 2026 (Class III). Only the lots, dates or models listed on this page are included.
Why was it 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 it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.