- Recalling firm
- Paragon 28, Inc.
- 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.
- Affected products (lot / model / serial)
- Lot Number AOCIA6123
- Units affected
- 1 unit
- Distribution pattern
- US Nationwide distribution i the state of MT.
- Firm location
- Englewood, CO, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2972-2026
- Recall initiated
- July 10, 2026
- FDA classification date
- August 14, 2026
- FDA report date
- August 26, 2026
- FDA event ID
- 99504
- Last updated on HTM Vibe
- September 8, 2026