DePuy Spine Recalls SKYLINE Anterior Cervical Plate System Screws
DePuy Spine is recalling 21 units of SKYLINE Anterior Cervical Plate System Constrained Self-Tapping Screws because Variable Ti screws may have been incorrectly packaged with them.
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 adverse health consequences. The source text describes a packaging mix-up without reporting specific injuries or illnesses, aligning with a moderate severity rating for a medical device recall.
Plain-English summary
DePuy Spine, Inc. is recalling 21 units of the SKYLINE Anterior Cervical Plate System Constrained Self-Tapping Screw, 4 x 18mm (Item Code: 186862018). The recall was initiated because SKYLINE Variable Ti screws may have been included within the packaging of the Constrained Ti screws.
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 items are AGFB1H, AGFB1V, and AGFBYK.
This recall is classified as Class II by the U.S. Food and Drug Administration. The SKYLINE Anterior Cervical Plate System 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 recalled product
- Product
- DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING SCREW 4 x 18mm Item Code: 186862018 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 o
- Manufacturer
- DePuy Spine, Inc.
- Affected units
- 21
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: AGFB1H AGFB1V AGFBYK
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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