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 temporary or medically reversible adverse health consequence. The hazard is a packaging mix-up of screw types, which is a significant quality control issue but does not explicitly report injuries or deaths in the source text.
Plain-English summary
DePuy Spine, Inc. is recalling the SKYLINE Anterior Cervical Plate System Variable Self-Tapping Screw 4.0 x 20mm (Item Code: 186852020). 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 product is identified by Lot Code ANNCJW. The recall covers 1 unit distributed to the following US states: CA, ID, IL, IN, KS, KY, LA, MO, NC, OR, PA, TX, VA, WA, and WV.
Healthcare providers and patients should check their inventory and records for this specific item code and lot number. If the product is found, it should be removed from use and returned to DePuy Spine, Inc. according to their instructions.
The recalled product
- Product
- DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 20mm Item Code: 186852020 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 orig
- Manufacturer
- DePuy Spine, Inc.
- Affected units
- 1
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: ANNCJW
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.
See all 7 products in this recall →Related recalls
Same manufacturer · DePuy Spine, Inc.
See all →- ModerateEIT CIF Cage Intervertebral Fusion Device Carton Labeling Mismatch Recall
FDA (Devices) · 2022-07-13
- ModerateIntervertebral fusion device recalled for outer carton labeling discrepancy
FDA (Devices) · 2022-07-13
- SevereDePuy Spine Recalls Concorde Lift Spinal Fusion Implants Due to Migration
FDA (Devices) · 2019-05-08
- HighDePuy Spine Recalls Concorde Lift Spinal Fusion Implants
FDA (Devices) · 2019-05-08
- HighDePuy Spine Recalls Confidence Plus Kit Spinal Cement System Lots
FDA (Devices) · 2018-04-11
Same hazard · mis labeling
See all →- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- HighByron White A-L Complex Herbal Supplement Recalled for Undeclared Walnut
FDA (Food) · 2026-09-02
- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02