The Recall Desk

FDA (Devices) recall action 75454

DePuy Spine, Inc. recalled 7 products on 2016-11-30

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
2016-11-30
Critical
0
Units
72

Why these products were recalled

SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.

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)··2016-11-30

    DePuy Spine Recalls SKYLINE Anterior Cervical Plate System Screws

    DePuy Spine is recalling 21 units of SKYLINE Anterior Cervical Plate System Constrained Self-Tapping Screws because Variable Ti screws may have been incorrectly packaged with them.

    Product
    DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING SCREW 4 x 18mm Item Code: 186862018 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic…
    Category
    Distribution
    15 states
  • ModerateFDA (Devices)··2016-11-30

    DePuy Spine Recalls SKYLINE Anterior Cervical Plate Screws

    DePuy Spine is recalling 12 SKYLINE Anterior Cervical Plate System screws because they may have been packaged with the wrong screw type.

    Product
    DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCREW 4.5 x 18mm Item Code: 186864018 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic…
    Category
    Distribution
    15 states
  • ModerateFDA (Devices)··2016-11-30

    DePuy Spine Recalls SKYLINE Anterior Cervical Plate System Screws

    DePuy Spine is recalling SKYLINE Variable Self-Tapping Screws because the packaging may contain Constrained Ti screws instead.

    Product
    DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 20mm Item Code: 186852020 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic…
    Category
    Distribution
    15 states
  • ModerateFDA (Devices)··2016-11-30

    DePuy Spine Recalls SKYLINE Anterior Cervical Plate System Screws

    DePuy Spine is recalling SKYLINE Variable Self-Tapping Screws because the packaging may contain Constrained Ti screws instead.

    Product
    DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 26mm Item Code: 186852026 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic…
    Category
    Distribution
    15 states
  • ModerateFDA (Devices)··2016-11-30

    DePuy Spine Recalls SKYLINE Anterior Cervical Plate System Screws

    DePuy Spine is recalling 9 units of SKYLINE Variable Self-Drilling Screws because they may have been packaged with Constrained Ti screws.

    Product
    DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm Item Code: 186850018 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic…
    Category
    Distribution
    15 states
  • ModerateFDA (Devices)··2016-11-30

    DePuy Spine Recalls SKYLINE Anterior Cervical Plate System Screws

    DePuy Spine is recalling 14 units of SKYLINE Variable Self-Drilling Screws because they may have been packaged with Constrained Ti screws.

    Product
    DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm Item Code: 186852018 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic…
    Category
    Distribution
    15 states
  • ModerateFDA (Devices)··2016-11-30

    DePuy Spine Recalls SKYLINE Anterior Cervical Plate Screws

    DePuy Spine is recalling 9 units of SKYLINE Variable Oversized Screws because they may have been packaged with Constrained Ti screws.

    Product
    DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW 4.5 x 18mm Item Code: 186854018 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic…
    Category
    Distribution
    15 states