Paragon 28, Inc.: Bone Wedge
Recall Summary Paragon 28, Inc. is recalling the Navicular Cage Small Right Rev A (Model 6123S R), a foot implant device, because the material contains elevated oxygen levels above allowable limits that may reduce its strength and flexibility. The device was distributed nationwide across all U.S. states and Washington, D.C. This is a Class II recall.
- Recalling firm
- 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 II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-07-10
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution i the state of MT.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/3231eb05-4213-490d-90f9-cb6f595002b4