DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm Ite...
FDA Device Recall #Z-0624-2017 — Class II — October 12, 2016
Recall Summary
| Recall Number | Z-0624-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 12, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | DePuy Spine, Inc. |
| Location | Raynham, MA |
| Product Type | Devices |
| Quantity | 9 units |
Product Description
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 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.
Reason for Recall
SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
Distribution Pattern
US Distribution to states of: CA, ID, IL, IN, KS, KY, LA, MO, NC, OR, PA, TX, VA, WA, and WV.
Lot / Code Information
AFNBMH AHJBC4 ANHFCW AHLBC4
Other Recalls from DePuy Spine, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1323-2022 | Class II | EIT CIF cage, H 6mm, 8degree, L- an interverteb... | May 20, 2022 |
| Z-1324-2022 | Class II | EIT CIF cage, H 7mm, 8degree, S- an interverteb... | May 20, 2022 |
| Z-1225-2019 | Class II | Concorde Lift, Expandable Interbody Device, spi... | Apr 8, 2019 |
| Z-1226-2019 | Class II | Concorde Lift, Lordotic Expandable Interbody De... | Apr 8, 2019 |
| Z-1300-2018 | Class II | Confidence Plus Kit Spinal Cement System, Produ... | Dec 15, 2017 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.