The Recall Desk

FDA (Devices) recall action 78640

SPINEART SA recalled 7 products on 2018-01-24

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
2018-01-24
Critical
0
Units
282

Why these products were recalled

Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the sketch/drawing of a self-drilling screw.

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–7 of 7

  • ModerateFDA (Devices)··2018-01-24

    Spineart Recalls Tryptik 2 C-Plate Screw Due to Labeling Error

    Spineart SA is recalling 15 units of Tryptik 2 C-Plate Self Tapping Screws because the product labeling incorrectly displays a sketch of a self-drilling screw.

    Product
    TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 16 MM, REF TRY-PS-45 16-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion…
    Category
    Distribution
    1 state
  • LowFDA (Devices)··2018-01-24

    Spineart Recalls Tryptik 2 C-Plate Screws Due to Labeling Error

    Spineart SA is recalling 16 units of Tryptik 2 C-Plate Self Tapping screws distributed in California because the product labeling contains an incorrect sketch of a self-drilling screw.

    Product
    TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 14 MM, REF TRY-PS-45 14-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion…
    Category
    Distribution
    1 state
  • LowFDA (Devices)··2018-01-24

    Spineart Recalls Tryptik 2 C-Plate Screw Due to Labeling Error

    Spineart SA is recalling 9 units of Tryptik 2 C-Plate Self-Tapping Screws because the product labeling displays a sketch of a self-drilling screw instead of the correct self-tapping screw.

    Product
    TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 12 MM, REF TRY-PS-45 12-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal…
    Category
    Distribution
    1 state
  • LowFDA (Devices)··2018-01-24

    Spineart Recalls Tryptik 2 C-Plate Screws Due to Labeling Error

    Spineart SA is recalling 8 units of Tryptik 2 C-Plate Self Tapping screws because the product labeling incorrectly displays a sketch of a self-drilling screw.

    Product
    TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 18 MM, REF TRY-PS-45 18-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion…
    Category
    Distribution
    1 state
  • LowFDA (Devices)··2018-01-24

    Spineart Recalls Tryptik 2 C-Plate Screws Due to Labeling Error

    Spineart SA is recalling 54 units of Tryptik 2 C-Plate self-tapping screws because the product labeling incorrectly displays a sketch of a self-drilling screw.

    Product
    TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 12 MM, REF TRY-PS-40 12-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion…
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2018-01-24

    Spineart Recalls Tryptik 2 C-Plate Screws Due to Labeling Error

    Spineart SA is recalling 120 units of Tryptik 2 C-Plate Self-Tapping Screws because the product labeling incorrectly displays a sketch of a self-drilling screw.

    Product
    TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 14 MM, REF TRY-PS-40 14-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion…
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2018-01-24

    Spineart Recalls Tryptik 2 C-Plate Screws Due to Labeling Error

    Spineart SA is recalling Tryptik 2 C-Plate self-tapping screws because the product labeling incorrectly displays a sketch of a self-drilling screw.

    Product
    TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 16 MM, REF TRY-PS-40 16-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion…
    Category
    Distribution
    1 state