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Phantom Hindfoot TTC/TC Nail System recallZ-2758-2026 · Paragon 28, Inc. · initiated Jun 17, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Paragon 28, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.

FDA root cause category: Under Investigation by firm

What the company is doing

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

Recall details

Recall number
Z-2758-2026
Status
Open, Classified
Initiated by the company
Jun 17, 2026
Posted by the FDA
Jul 17, 2026
Recalling firm
Paragon 28, Inc.
Quantity
514 units
Product code
HXI
Distribution
US nationwide, Australia, Canada, The Netherlands, and New Zealand

Product description

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.

Code information (models, lots, serial numbers)

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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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