The Recall Desk

FDA (Devices) recall action 85830

TeDan Surgical Innovations LLC recalled 7 products on 2020-07-15

The FDA (Devices) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.

Products
7
Announced
2020-07-15
Critical
0
Units
—

Why these products were recalled

Lack of pouch seal. Product is labelled as sterile.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–7 of 7

  • HighFDA (Devices)··2020-07-15

    TeDan Phantom CS Quick Start Distraction Screw Recall for Seal Defect

    TeDan Surgical Innovations LLC is recalling 730 sterile Phantom CS Quick Start Distraction Screws due to a lack of pouch seal.

    Product
    PHANTOM CS QUICK START DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
    Category
    Distribution
    19 states
  • HighFDA (Devices)··2020-07-15

    TeDan Phantom CS Distraction Screw Recall for Lack of Pouch Seal

    TeDan Surgical Innovations LLC is recalling 1,965 Phantom CS Distraction Screws because the packaging lacks a pouch seal, compromising the sterile labeling.

    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.
    Category
    Distribution
    19 states
  • HighFDA (Devices)··2020-07-15

    TeDan 3COR Distraction Screw Recall Due to Sterility Seal Failure

    TeDan Surgical Innovations LLC is recalling 3COR Distraction Screws because the pouch seal is lacking, compromising the sterile labeling.

    Product
    3COR DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
    Category
    Distribution
    19 states
  • ModerateFDA (Devices)··2020-07-15

    TeDan 3COR Distraction Screw Recall Due to Pouch Seal Defect

    TeDan Surgical Innovations is recalling 3COR Distraction Screws because the sterile pouch seal is defective, potentially compromising sterility.

    Product
    3COR DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
    Category
    Distribution
    19 states
  • HighFDA (Devices)··2020-07-15

    TeDan Phantom CS Distraction Screw Recalled for Sterility Seal Defect

    TeDan Surgical Innovations LLC is recalling 495 Phantom CS Quick Start Distraction Screws because the pouch seal is lacking, compromising the sterile labeling.

    Product
    PHANTOM CS QUICK START DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
    Category
    Distribution
    19 states
  • HighFDA (Devices)··2020-07-15

    TeDan Phantom CS Distraction Screw Recalled for Lack of Pouch Seal

    TeDan Surgical Innovations is recalling 1,965 sterile Phantom CS Distraction Screws because the packaging lacks a pouch seal, compromising the sterile claim.

    Product
    PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
    Category
    Distribution
    19 states
  • HighFDA (Devices)··2020-07-15

    TeDan Phantom CS Quick Start Distraction Screw Recall for Seal Defect

    TeDan Surgical Innovations LLC is recalling 340 sterile Phantom CS Quick Start Distraction Screws due to a lack of pouch seal.

    Product
    PHANTOM CS QUICK START DISTRACTION SCREW, 16 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
    Category
    Distribution
    19 states