Recall Z-0627-2017— DePuy Spine, Inc.
Class II · Terminated
Class II FDA medical device recall by DePuy Spine, Inc., initiated 2016-10-12, terminated 2017-09-18. It names one FDA 510(k) clearance: K052552. 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.. Reason: SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging..
- Recalling firm
- DePuy Spine, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-10-12
- Terminated
- 2017-09-18
- Firm location
- Raynham, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
Data sourced from openFDA. This site is unofficial and independent of the FDA.