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.
FDA Recall Z-2758-2026 · Posted 2026-07-17
Recalling FirmParagon 28, Inc.
Recall StatusOpen, Classified
Product CodeHXI
Date Initiated2026-06-17
Product Quantity514 units
Reason for Recall
Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
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. Alternatively, you may directly return all affected product from your facility.
i. Complete Attachment 1 Certificate of Acknowledgement for each return and send to [email protected].
ii. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing.
iii. Mark RECALL on the outside of the returned cartons
3. If the product has been further distributed, provide your customers with this notice and ensure documentation.
4. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. This form shall be returned even if you do not have affected products at your facility.
5. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facility s documentation.
6. If you have further questions or concerns after reviewing this notice, please call 888-728-1888. Alternatively, your questions may be emailed to [email protected].
Surgeon Responsibilities:
1. Review this notification for awareness of the contents.
2. There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule.
3. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected].
4. Retain a copy of
Root Cause
Under Investigation by firm
Distribution Pattern
US nationwide, Australia, Canada, The Netherlands, and New Zealand
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.