Recall Z-2971-2026 ยท PLF Bone Wedge
Paragon 28, Inc.
Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant
| Date | Aug 14, 2026 (initiated Jul 10, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | Paragon 28 issued an URGENT MEDICAL DEVICE RECALL to its consignees on 7/14/2026 via FedEx 2nd day. The notice explained the issue, potential risk, and requested the following: Distributors: "Your Responsibilities 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete Attachment 1 Inventory Return Certification Form for each return and send |
| Quantity | 1 |
| Distribution | US Nationwide distribution i the state of MT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.