Paragon 28, Inc.: P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number P31-955-1
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Paragon 28, Inc.
- 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.
- Reason / hazard
- Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US nationwide, Australia, Canada, The Netherlands, and New Zealand
- Recall initiated
- 2026-06-17
- Code info
- 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.
- Product quantity
- 514 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Englewood
- State
- CO
- Country
- United States
- Event id
- 99276
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