Paragon 28, Inc. recalls Custom Made Device Implant 6123 Navicular Cage Small Right Rev A
- Recalling company
- Paragon 28, Inc.
- Product
- Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant
- 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.
- Classification
- Class III – not likely to cause adverse health consequences
- Recall date
- Jul 10, 2026
- Reported
- Aug 26, 2026
- Distribution
- US Nationwide distribution i the state of MT.
- Status
- Ongoing
- Quantity
- 1
- Lot / codes
- Lot Number AOCIA6123
- Company location
- Englewood, CO
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2971-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2971-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.