Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW Recalled by DePuy Spine, Inc. Due to SKYLINE Variable Ti screws may have contained SKYLINE...

Date: October 12, 2016
Company: DePuy Spine, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact DePuy Spine, Inc. directly.

Affected Products

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 origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthosis , trauma (i.e., fracture or dislocation), deformities (i.e. cervical kyphosis, and/or lordosis), tumor, spinal canal stenosis, and cervical myelopathy.

Quantity: 6 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 15 states: CA, ID, IL, IN, KS, KY, LA, MO, NC, OR, PA, TX, VA, WA, WV

Affected (15 states)Not affected

About DePuy Spine, Inc.

DePuy Spine, Inc. has 36 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report