Z-0628-2017Class II

DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW 4.5 x 18mm Item Code: 186854018...

Name: Z-0628-2017 DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW 4.5 x 18mm Item Code: 186854018...
Creator: DePuy Spine, Inc.
Published: 2016-10-12
License: https://open.fda.gov/license/

DePuy Spine, Inc. / initiated 2016-10-12 / Terminated / root cause: packaging

FDA source

DePuy Spine, Inc. began a recall of DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW 4.5 x 18mm Item Code: 186854018 The SKYLINE Anterior Cervical Plate System is... on 2016-10-12. FDA classified it as Class II and gives the reason as "SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0628-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-12
Posted: 2016-11-19
Terminated: 2017-09-18
Recalling firm: DePuy Spine, Inc.
Product: 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.
Product code: KWQ Appliance, Fixation, Spinal Intervertebral Body
Reason for recall: SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
Root cause tag: packaging
FDA root cause: 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: [email protected] 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- [email protected]).
Quantity in commerce: 9 units
Distribution: US Distribution to states of: CA, ID, IL, IN, KS, KY, LA, MO, NC, OR, PA, TX, VA, WA, and WV.
Product codes and lots: Lot Codes: AFFBMZ AFN6D5 AMMDVJ

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0628-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0624-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-30	2016-11-19
Z-0625-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-30	2016-11-19
Z-0626-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-30	2016-11-19
Z-0627-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-30	2016-11-19
Z-0628-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-30	2016-11-19
Z-0629-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-30	2016-11-19
Z-0630-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-30	2016-11-19

Product code KWQ

K052552Class IIHybrid Anterior Cervical Plate SystemDepuy Spine, Inc. / cleared 2005-10-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)