FDA Medical devices recall ·
Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model recall
- Recall number
- Z-2971-2026
- Date
- (initiated July 10, 2026)
- Company / brand
- Paragon 28, Inc.
14445 Grasslands Dr, Englewood, CO, United States - Category
- Medical devices › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 1
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant
Why was it recalled?
Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Number AOCIA6123
Distribution
US Nationwide distribution i the state of MT.
States: Montana
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (medical devices), recall Z-2971-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.