Class II — DePuy Spine, Inc.
| Recalling firm | DePuy Spine, Inc. |
|---|---|
| Registered facility | DEPUY SPINE, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. |
| 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. |
| Quantity | 6 units |
| Distribution | US Distribution to states of: CA, ID, IL, IN, KS, KY, LA, MO, NC, OR, PA, TX, VA, WA, and WV. |
| Initiated | 2016-10-12 |
| Classified | 2016-11-19 |
| Terminated | 2017-09-18 |
| Recall number | Z-0627-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — DePuy Spine, Inc. (Z-0627-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75454/
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