FDA recall, , Moderate risk
Paragon 28 Phantom Hindfoot TTC/TC Ball Tipped Guide Rod
The P28 Phantom Intramedullary Nail System guide rod has breaches in its sterile barrier.
Summary by Recall Canary from the FDA notice
What happened
Paragon 28, Inc., of Englewood, Colorado, is recalling the 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, which provides stabilization of the hindfoot and ankle. The recall was initiated after the company received two complaints involving breaches in the sterile barrier of the pouch packaging.
The product was distributed nationwide and to Australia, Canada, The Netherlands, and New Zealand. Paragon 28 began the recall on June 17, 2026, and the FDA added it to its Enforcement Report on July 17, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI or item number is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
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.
- UDI-DI
- 00889795061577
- 501167202225
- 501167302225
- 501209514725
- 501259627925
- 501275832225
- Recall number
- Z-2758-2026
- Item number
- P31-955-1800-S
Recall details
- Company began the recall
- Sold in
US nationwide, Australia, Canada, The Netherlands, and New Zealand
- Company
- Paragon 28, Inc.Englewood, Colorado
- Hazard
- Sterility problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99276
- Recall number
- Z-2758-2026
- Quantity recalled
- 514 units
All recalls from Paragon 28, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
