Device recall: DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-‐DRILLING SCREW 4.0 x 18mm Item Code: 186850018 The…

Class II FDA enforcement event 75454. Recall start date: 12 Oct 2016. Status in the FDA record: Terminated. Termination date: 18 Sep 2017.

Reason for recall, in the words of FDA

SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

DePuy Spine, Inc. started this device recall on 12 Oct 2016. The firm address in the FDA record is in Raynham, MA. FDA put the recall in Class II. FDA event 75454 has 7 product records. The first FDA enforcement report date is 30 Nov 2016. The record gives the status Terminated, with the termination date 18 Sep 2017.

FDA enforcement report The 7 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

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.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

7 product records in the event.

FDA event 75454: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0624-2017	DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-‐DRILLING SCREW 4.0 x 18mm Item Code: 186850018 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…	9 units	Class II	Terminated	30 Nov 2016
Z-0625-2017	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…	14 units	Class II	Terminated	30 Nov 2016
Z-0626-2017	DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 20mm Item Code: 186852020 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…	1 unit	Class II	Terminated	30 Nov 2016
Z-0627-2017	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…	6 units	Class II	Terminated	30 Nov 2016
Z-0628-2017	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…	9 units	Class II	Terminated	30 Nov 2016
Z-0629-2017	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…	21 units	Class II	Terminated	30 Nov 2016
Z-0630-2017	DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCREW 4.5 x 18mm Item Code: 186864018 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…	12 units	Class II	Terminated	30 Nov 2016

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2016: 1,232
Share of these events in Class II: 91%
Product records in this event: 7Median of the firm: 2
Events of the firm on the register: 11

Other events of the firm

Other FDA enforcement events of DePuy Spine, Inc.
Initiated	Product (first record)	Type	Class	Records
20 May 2022	EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use with autograft when used as an	Device	Class II	2
8 Apr 2019	Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (19	Device	Class II	2
15 Dec 2017	Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000 (GTIN: (01)1	Device	Class II	1
20 Nov 2015	Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate Syst	Device	Class II	1
21 Apr 2015	EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER	Device	Class II	1
31 Jul 2013	PIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated The PIPLINE LS Dilators and Holding Clip are intended for sequent	Device	Class II	5
17 Apr 2013	CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000 The CONFIDENCE Spinal Cement System is intended for p	Device	Class II	3
15 Jan 2013	DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. Delivery of CONFIDENCE Spinal Cement, which is i	Device	Class II	4
7 Nov 2012	DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl Product Code: 1867-15-870 Spinal Implant Component.	Device	Class II	9
24 Jul 2012	DePuy Spine EXPEDIUM Offset Torque Wrench Product Code 2797-29-510 The device is intended for use during the final tight	Device	Class II	1

DePuy Spine, Inc.: all 11 events

Official channels

FDA enforcement report Z-0624-2017The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 75454. https://recallregister.com/fda/ii/75454/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: US Distribution to states of: CA, ID, IL, IN, KS, KY, LA, MO, NC, OR, PA, TX, VA, WA, and WV.
What quantity of product is in FDA event 75454?: The event has 7 product records. The first record gives this quantity: 9 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2016 have the same class?: 91% of the 1,232 device events that started in 2016 are in Class II.