Z-2758-2026Class II

P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH...

Name: Z-2758-2026 P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH...
Creator: Paragon 28, Inc.
Published: 2026-06-17
License: https://open.fda.gov/license/

Paragon 28 / initiated 2026-06-17 / Open, Classified / root cause: packaging

FDA source

Paragon 28, Inc. began a recall of 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... on 2026-06-17. FDA classified it as Class II and gives the reason as "Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2758-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-17
Posted: 2026-07-17
Recalling firm: Paragon 28
Product: 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.
Product code: HXI Passer, Wire, Orthopedic
Reason for recall: Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
Root cause tag: packaging
FDA 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. 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
Quantity in commerce: 514 units
Distribution: US nationwide, Australia, Canada, The Netherlands, and New Zealand
Product codes and lots: UDI (01)00889795061577(17)300122(10)501167202225, Lot Number 501167202225; UDI (01)00889795061577(17)300122(10)501167302225, Lot Number 501167302225; UDI (01)00889795061577(17)300527(10)501209514725, Lot Number 501209514725; UDI (01)00889795061577(17)301006(10)501259627925, Lot Number 501259627925; UDI (01)00889795061577(17)301118(10)501275832225, Lot Number 501275832225.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2758-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2758-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-17

Product code HXI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)