DePuy Spine Recalls SKYLINE Anterior Cervical Plate System Screws
DePuy Spine is recalling 14 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, and the source text describes a packaging mix-up without reporting any specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity rating.
Plain-English summary
DePuy Spine, Inc. is recalling 14 units of the SKYLINE Anterior Cervical Plate System Variable Self-Drilling Screw 4.0 x 18mm (Item Code: 186852018). The recall was initiated because the SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
The affected 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 specific lot codes for the recalled items are AMMBPW, AMPCML, ANCDJ0, and APPBYD.
The SKYLINE Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for various spinal conditions, including degenerative disc disease, pseudoarthrosis, trauma, deformities, tumor, spinal canal stenosis, and cervical myelopathy. Healthcare providers and patients should verify the lot codes of their inventory or implanted devices against the recalled list. If a device matches the recalled lot codes, it should be removed from use and returned to the manufacturer or reported to the FDA.
The recalled product
- Product
- DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm Item Code: 186852018 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
- 14
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: AMMBPW AMPCML ANCDJ0 APPBYD
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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