Paragon 28 Phantom Hindfoot Guide Rod recalled for sterile packaging breach
Paragon 28 received two complaints about breaches in the sterile barrier packaging of specific lots of the Phantom Hindfoot TTC/TC Ball Tipped Guide Rod (0.30 mm, 800 mm). The packaging breach could potentially allow contamination of the surgical device before use. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All Paragon 28 recalls
What to do
- Check the lot number on your Paragon 28 guide rod packaging (five lot numbers affected: 501167202225, 501167302225, 501209514725, 501259627925, 501275832225).
- If you have an affected unit, do not use it and contact your supplier or Paragon 28 immediately.
- Return the device for a replacement or credit.
Is yours affected?
Compare your label or packaging with the recalled product.
- 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.
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 514 units
- Illnesses reported
- None reported
- Manufactured in
- 14445 Grasslands Dr, N/A, Englewood, CO, United States
- Classification
- Class II
- Recall number
- Z-2758-2026
In the FDA's words
- 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. Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging. 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. Distribution: US nationwide, Australia, Canada, The Netherlands, and New Zealand Affected quantity: 514 units
- Hazard
- Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
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ModerateFDAAug 26, 2026