DeviceSignal · Recall classified
Paragon 28, Inc.
FDA classified a device recall on 2026-08-14 · Class III · Z-2971-2026
EventRecall classified
Effective2026-08-14
ClassificationClass III
On 2026-08-14 the FDA classified a device recall from Paragon 28, Inc. as Class III. Product: Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number…. Recall Z-2971-2026. The firm initiated it on 2026-07-10. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2971-2026
- Classification
- Class III
- Classified on
- 2026-08-14
- Initiated on
- 2026-07-10
- Firm
- Paragon 28, Inc.
- Reason
- 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
- Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-2971-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
28e1a974c9e81ac182e51e32ae0ec729602ae066f2f54cab01b6da86343881a4- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)