Recall Z-0629-2017
DePuy Spine, Inc. · initiated October 12, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot Codes: AGFB1H AGFB1V AGFBYK
Reason for recall
SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
FDA-determined cause: Under Investigation by firm
Action taken
The firm, DePuy Synthes Spine, sent an "URGENT! VOLUNTARY PRODUCT CORRECTION NOTIFICATION" letter dated 10/12/2016 to its Customers. Sales consultants supporting these customers received an email notification with required reply forms. The letter described the product, problem and actions to be taken. A DePuy Synthes Spine Sales consultant has been notified and will be reviewing inventory to ensure correct screw placement within your set. The customers were instructed to review, complete, sign and return the attached business reply form to DePuy Synthes Spine via email to: DPYUS-SpineFieldActions@its.jnj.com within 5 business days of receipt of this notification; forward the notice to anyone in your facility that needs to be informed; if devices have been forwarded to another facility, contact that facility and provide them with notice, and keep a copy of the notice. Questions about this recall, please contact Recall Coordinator, DePuy Synthes Spine (via telephone: 508.828.3647 or via email: DPYUS- SpineFieldActions@its.jnj.com).
Details
- Recall number
- Z-0629-2017
- Initiated
- October 12, 2016
- Terminated
- September 18, 2017
- Product code
- KWQ – Appliance, Fixation, Spinal Intervertebral Body
- Quantity
- 21 units
- Distribution
- US Distribution to states of: CA, ID, IL, IN, KS, KY, LA, MO, NC, OR, PA, TX, VA, WA, and WV.
- Recalling firm
- DePuy Spine, Inc., Raynham, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0624-2017 Class II | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x…SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | 10/12/2016Terminated |
| Z-0625-2017 Class II | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x…SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | 10/12/2016Terminated |
| Z-0626-2017 Class II | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x…SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | 10/12/2016Terminated |
| Z-0627-2017 Class II | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x…SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | 10/12/2016Terminated |
| Z-0628-2017 Class II | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW 4.5 x 18mm…SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | 10/12/2016Terminated |
| Z-0630-2017 Class II | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCREW 4.5 x…SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | 10/12/2016Terminated |