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U.S. Department of Health and Human Services

Class 2 Device Recall DePuy Spine

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 Class 2 Device Recall DePuy Spinesee related information
Date Initiated by FirmOctober 12, 2016
Create DateNovember 19, 2016
Recall Status1 Terminated 3 on September 18, 2017
Recall NumberZ-0627-2017
Recall Event ID 75454
510(K)NumberK052552 
Product Classification Appliance, fixation, spinal intervertebral body - Product Code KWQ
ProductDePuy 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.
Code Information Lot Codes: DFLBGO
Recalling Firm/
Manufacturer		 DePuy Spine, Inc.
325 Paramount Dr
Raynham MA 02767-5199
For Additional Information ContactSAME
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
ActionThe 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 Commerce6 units
DistributionUS Distribution to states of: CA, ID, IL, IN, KS, KY, LA, MO, NC, OR, PA, TX, VA, WA, and WV.
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = KWQ
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