Device product
DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 20mm Item Code: 186852020 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.
Z-0626-2017
Product summary
- Event
- Event 75454
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-0626-2017
Official wording
Reason: SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
Code information: Lot Codes: ANNCJW
Distribution pattern: US Distribution to states of: CA, ID, IL, IN, KS, KY, LA, MO, NC, OR, PA, TX, VA, WA, and WV.
Derived failure modes
-
Unknown
SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.