Recall Z-2758-2026 ยท HXI Passer, Wire, Orthopedic
Paragon 28, Inc.
P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number P31-955-1800-S; provides stabilization of the hindfoot and ankle.
| Date | Jul 17, 2026 (initiated Jun 17, 2026) |
| Status | Open, Classified |
| Reason | Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging. |
| Root cause | Under Investigation by firm |
| Action | Paragon 28 issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 6/22/2026 via email and courier. The notice explained the issue, risks associated with the use of the affected product, and requested the following: "Risk Manager Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, immediately locate and quarantine affected product in your inventory. a. Your Paragon 28 sales representative may remove and return the affected product from your facility on your behalf. b. Al |
| Quantity | 514 units |
| Distribution | US nationwide, Australia, Canada, The Netherlands, and New Zealand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.