DePuy Spine Recalls SKYLINE Anterior Cervical Plate Screws
DePuy Spine is recalling 12 SKYLINE Anterior Cervical Plate System screws because they may have been packaged with the wrong screw type.
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, and the source text describes a packaging error without reporting any specific injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
DePuy Spine, Inc. is recalling 12 units of the SKYLINE Anterior Cervical Plate System Constrained Oversized Screw 4.5 x 18mm (Item Code: 186864018). The recall was initiated because SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
The affected units are 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 specific lot codes for the recalled units are 1GFBQW, AGFB01, and AGFB0W.
The SKYLINE Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for various spinal conditions. Consumers and healthcare providers should verify the lot codes of their inventory against the recalled list and contact DePuy Spine for further instructions.
The recalled product
- Product
- DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCREW 4.5 x 18mm Item Code: 186864018 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
- 12
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: 1GFBQW AGFB01 AGFB0W
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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