DePuy Spine Recalls SKYLINE Anterior Cervical Plate System Screws
DePuy Spine is recalling SKYLINE Variable Self-Tapping Screws because the packaging may contain Constrained Ti screws instead.
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 situation where use of the product may cause temporary or medically reversible health consequences. The issue is a packaging mix-up rather than a material defect or reported injury, fitting the Moderate severity criteria for minor labeling or packaging errors.
Plain-English summary
DePuy Spine, Inc. is recalling 6 units of the SKYLINE Anterior Cervical Plate System Variable Self-Tapping Screw 4.0 x 26mm (Item Code: 186852026). The recall is due to a packaging error where SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
The affected units are from Lot Code DFLBGO. These products 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 SKYLINE Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for various spinal conditions. Healthcare providers and patients should verify the specific screw type in their inventory or surgical records to ensure the correct component was used.
The recalled product
- Product
- 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 ori
- Manufacturer
- DePuy Spine, Inc.
- Affected units
- 6
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)
- Lot Codes: DFLBGO
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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