CLASS III ONGOING Device recall · Reported 26 Aug 2026 · FDA Enforcement Report
Custom Made Device Implant 6123 Navicular Cage Nominal Right recalled
Paragon 28 is recalling Custom Made Device Implant 6123 Navicular Cage Nominal Right, distributed nationwide in the US. The recall was initiated on 10 Jul 2026 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2972-2026
- FDA event ID
- 99504
- Recalling firm
- Paragon 28, Englewood, CO
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 10 Jul 2026
- FDA classified
- 14 Aug 2026
- Reported
- 26 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 10 Jul 2026 | Recall initiated by company | |
| 14 Aug 2026 | Classified by FDA | +35 days |
| 26 Aug 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
Product as listed by the FDA
Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant
Where it was distributed
US Nationwide distribution i the state of MT.
Questions about this recall
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.
Which lots are affected?
Lot Number AOCIA6123
Where was it sold?
US Nationwide distribution i the state of MT.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 99504This product is part of a recall event; the main page for the event is Custom Made Device Implant 6123 Navicular Cage Small Right recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Custom Made Device Implant 6123 Navicular Cage Small Right recalled | Paragon 28 | Other | Nationwide |
More recalls from Paragon 28
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Custom Made Device Implant 6123 Navicular Cage Small Right recalled | Paragon 28 | Other | Nationwide |
| Device | CLASS II | P28 Phanton Intramedullary Nail System recalled by Paragon 28 | Paragon 28 | Sterility | Nationwide |
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| Device | CLASS II | Phantom TTC Nail, TTC Nail, 10.0, Right recalled by Paragon 28 | Paragon 28 | Sterility | CA |
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