medical Class II Updated 2020-07-15

TeDan Surgical Innovations LLC recalls PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Produ

Recalled Product

PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.


Hazard / Issue

Lack of pouch seal. Product is labelled as sterile.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Product Code: DS-0012 UDI Number: 00851797006443 Lot Number: 2018021901 2018061101
View official government recall

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