RecallRadar

FDA Device recall Z-0627-2017

DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 26mm Item Code: 186852026 The SKYLINE¿ Anterior Cervic…

On 2016-11-30 the FDA classified a Class II recall of DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 26mm Item Code: 186852026 The SKYLINE¿ Anterior Cervic… by Depuy Spine, citing SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0627-2017
ClassificationClass II
Statusterminated
Initiated2016-10-12
Published2016-11-30
Last updated2026-09-13 11:54 UTC
CompanyDepuy Spine
DistributionCA, ID, IL, IN, KS, KY, LA, MO, NC, OR, PA, TX, VA, WA, WV

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 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.

Reason

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

Identifiers

code_infoLot Codes: DFLBGO

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Other recalls by Depuy Spine

All Depuy Spine recalls

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0627-2017%22

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