CLASS II Device recall · Reported 30 Nov 2016 · FDA Enforcement Report
Skyline Anterior Cervical Plate System Variable Oversized Screw recalled
DePuy Spine is recalling Skyline Anterior Cervical Plate System Variable Oversized Screw 4.5, distributed in 15 states. The recall was initiated on 12 Oct 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0628-2017
- FDA event ID
- 75454
- Recalling firm
- DePuy Spine, Raynham, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Oct 2016
- FDA classified
- 19 Nov 2016
- Reported
- 30 Nov 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Spinal Implants
Timeline
| 12 Oct 2016 | Recall initiated by company | |
| 19 Nov 2016 | Classified by FDA | +38 days |
| 30 Nov 2016 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
US Distribution to states of: CA, ID, IL, IN, KS, KY, LA, MO, NC, OR, PA, TX, VA, WA, and WV.
CaliforniaIdahoIllinoisIndianaKansasKentuckyLouisianaMissouriNorth CarolinaOregonPennsylvaniaTexasVirginiaWashingtonWest Virginia
Questions about this recall
Why was it recalled?
SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
Which lots are affected?
Lot Codes: AFFBMZ AFN6D5 AMMDVJ
Where was it sold?
US Distribution to states of: CA, ID, IL, IN, KS, KY, LA, MO, NC, OR, PA, TX, VA, WA, and WV.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 75454This product is part of a recall event; the main page for the event is Skyline Anterior Cervical Plate System Variable recalled by DePuy Spine.
More recalls from DePuy Spine
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | EIT CIF cage, H, 8degree, L- an intervertebral body fusion recalled | DePuy Spine | Packaging Defects | Nationwide |
| Device | CLASS II | EIT CIF cage, H, 8degree, S- an intervertebral body fusion recalled | DePuy Spine | Packaging Defects | Nationwide |
| Device | CLASS II | Concorde Lift, Lordotic Expandable Interbody Device recalled | DePuy Spine | Other | Nationwide |
| Device | CLASS II | Concorde Lift, Expandable Interbody Device recalled by DePuy Spine | DePuy Spine | Other | Nationwide |
| Device | CLASS II | Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 recalled | DePuy Spine | Other | MA |
Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |