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DePuy Spine, Inc. recalls DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING SCREW 4 x 18mm Item Code: 186862018 Th
Recalled November 30, 2016 · FDA recall Z-0629-2017 · DePuy Spine
Hazard
SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. · FDA Class II
Units
21 units
Sold at
US Distribution to states of: CA, ID, IL, IN, KS, KY, LA, MO, NC, OR, PA, TX, VA, WA, and WV.
Description
SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
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.
Manufacturer(s)
DePuy Spine, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →