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.
What this means for you
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.
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