DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED… — Class II medical device recall Z-0629-2017
Terminated recall by DePuy Spine, Inc., reported 2016-11-30, distributed in CA, ID, IL, IN, KS, KY, LA, MO…. SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
| Recall number | Z-0629-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Spine, Inc., Raynham, MA, United States |
| Recall initiated | 2016-10-12 |
| Classified | 2016-11-19 |
| Reported by FDA | 2016-11-30 |
| Terminated | 2017-09-18 |
| Distributed | CA, ID, IL, IN, KS, KY, LA, MO, NC, OR, PA, TX, VA, WA, WV |
| Quantity | 21 units |
| Lot numbers | AGFB1H, AGFB1V |
| Model numbers | 186862018 |
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 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 for recall
SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0629-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.