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 P31-955-1800-S; provides stabilization of the hindf

Hazard

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

Details from the source

Reason for recall: Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging. Distribution: US nationwide, Australia, Canada, The Netherlands, and New Zealand Quantity: 514 units Lot/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.

UPC codes

00889795061577, 501167202225, 501167302225, 501209514725, 501259627925, 501275832225

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.