DePuy Spine Recalls SKYLINE Anterior Cervical Plate Screws
DePuy Spine is recalling 9 units of SKYLINE Variable Oversized 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 involves a packaging mix-up of similar medical device components. No injuries or illnesses are reported in the source text, and the hazard is a potential procedural error rather than a direct physical defect causing harm.
Plain-English summary
DePuy Spine, Inc. is recalling 9 units of the SKYLINE Anterior Cervical Plate System Variable Oversized Screw 4.5 x 18mm (Item Code: 186854018). 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 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 AFFBMZ, AFN6D5, and AMMDVJ.
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 lot codes of their inventory or implanted devices against the recalled list. If a unit matches the recalled lot codes, it should be returned to DePuy Spine, Inc.
The recalled product
- Product
- DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW 4.5 x 18mm Item Code: 186854018 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)
- Lot Codes: AFFBMZ AFN6D5 AMMDVJ
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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