DePuy Spine Recalls SKYLINE Anterior Cervical Plate System Screws
DePuy Spine is recalling 9 units of SKYLINE Variable Self-Drilling Screws because they may have been packaged with Constrained Ti screws.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a temporary or medically reversible adverse health consequence. The hazard is a packaging error involving the wrong screw type, with no reported injuries or illnesses in the source text.
Plain-English summary
DePuy Spine, Inc. is recalling 9 units of the SKYLINE Anterior Cervical Plate System Variable Self-Drilling Screw 4.0 x 18mm (Item Code: 186850018). The recall was initiated because the Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
The affected product is indicated for stabilization from C2 to C7 for conditions including degenerative disc disease, pseudoarthrosis, trauma, deformities, tumor, spinal canal stenosis, and cervical myelopathy. The 9 units were distributed in the United States to the states of California, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Missouri, North Carolina, Oregon, Pennsylvania, Texas, Virginia, Washington, and West Virginia.
The source text does not specify instructions for consumers or healthcare providers regarding the disposition of the recalled units.
The recalled product
- Product
- 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…
- Manufacturer
- DePuy Spine, Inc.
- Affected units
- 9
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- AFNBMH AHJBC4 ANHFCW AHLBC4
Distribution
Part of a larger recall action
This product is one of 7 recalled by DePuy Spine, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
Same manufacturer · DePuy Spine, Inc.
See all →- ModerateEIT CIF Cage Intervertebral Fusion Device Carton Labeling Mismatch Recall
FDA (Devices) · 2022-07-13
- ModerateIntervertebral fusion device recalled for outer carton labeling discrepancy
FDA (Devices) · 2022-07-13
- SevereDePuy Spine Recalls Concorde Lift Spinal Fusion Implants Due to Migration
FDA (Devices) · 2019-05-08
- HighDePuy Spine Recalls Concorde Lift Spinal Fusion Implants
FDA (Devices) · 2019-05-08
- HighDePuy Spine Recalls Confidence Plus Kit Spinal Cement System Lots
FDA (Devices) · 2018-04-11
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- SeverePioneer Surgical Technology Recalls CervAlign Anterior Cervical Plate System
FDA (Devices) · 2021-03-17
- SevereRTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Failure
FDA (Devices) · 2021-03-17
- SevereCervAlign Anterior Cervical Plate System Recalled for Locking Mechanism Failure
FDA (Devices) · 2021-03-17
- SevereRTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure
FDA (Devices) · 2021-03-17
- SevereFDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure
FDA (Devices) · 2021-03-17
- SevereRTI Surgical Recalls CervAlign Anterior Cervical Plate System
FDA (Devices) · 2021-03-17