Paragon 28, Inc.: Bone Wedge
Recall Summary Paragon 28, Inc. is recalling the Bone Wedge Model 6123N R, a foot implant device used in foot surgery. The device was recalled because oxygen levels in the material exceeded allowable limits, which could reduce how well the implant material bends or flexes. The affected implant was distributed nationwide across the United States.
- Recalling firm
- Paragon 28, Inc.
- Product
- Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N 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/86af7e0c-f3a6-48ea-afa6-d32ffd46ac3d