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, Inc.
The hazard
Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
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.
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model UDI (01)00889795061577(17)300122(10)501167202225Model Lot Number 501167202225Model UDI (01)00889795061577(17)300122(10)501167302225Model Lot Number 501167302225Model UDI (01)00889795061577(17)300527(10)501209514725Model Lot Number 501209514725Model UDI (01)00889795061577(17)301006(10)501259627925Model Lot Number 501259627925Model UDI (01)00889795061577(17)301118(10)501275832225Model Lot Number 501275832225.UPC 00889795061577UPC 501167202225UPC 501167302225UPC 501209514725UPC 501259627925UPC 501275832225Would you have heard about this one?
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