Z-0628-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 30, 2016
- Initiation Date
- October 12, 2016
- Termination Date
- September 18, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 units
Product Description
DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW 4.5 x 18mm Item Code: 186854018 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.
Distribution Pattern
US Distribution to states of: CA, ID, IL, IN, KS, KY, LA, MO, NC, OR, PA, TX, VA, WA, and WV.
Code Information
Lot Codes: AFFBMZ AFN6D5 AMMDVJ