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…
- FDA Device
- Class II
- terminated
- Published 2016-11-30
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
| Agency | FDA Device |
|---|---|
| Recall number | Z-0627-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-12 |
| Published | 2016-11-30 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Depuy Spine |
| Distribution | CA, 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_info | Lot Codes: DFLBGO |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0627-2017%22
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