| Class 2 Device Recall DePuy Spine | |
Date Initiated by Firm | October 12, 2016 |
Create Date | November 19, 2016 |
Recall Status1 |
Terminated 3 on September 18, 2017 |
Recall Number | Z-0625-2017 |
Recall Event ID |
75454 |
510(K)Number | K052552 |
Product Classification |
Appliance, fixation, spinal intervertebral body - Product Code KWQ
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Product | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm
Item Code: 186852018
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. |
Code Information |
Lot Codes: AMMBPW AMPCML ANCDJ0 APPBYD |
Recalling Firm/ Manufacturer |
DePuy Spine, Inc. 325 Paramount Dr Raynham MA 02767-5199
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For Additional Information Contact | SAME 508-828-3769 |
Manufacturer Reason for Recall | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | 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). |
Quantity in Commerce | 14 units |
Distribution | US Distribution to states of: CA, ID, IL, IN, KS, KY, LA, MO, NC, OR, PA, TX, VA, WA, and WV. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = KWQ
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