Stryker UniVise Spinous Process Fixation Plate System Inserter Recalled
Stryker Spine is recalling 41 units of the UniVise Spinous Process Fixation Plate System Inserter because the inner shaft does not fit through the device.
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 defect is a mechanical fit issue with no reported injuries or illnesses, aligning with the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Stryker Spine is recalling 41 units of the UniVise Spinous Process Fixation Plate System Inserter, Reference Number 48590100. The affected lots are B40155, B34446, B34447, and B41171. The product is a non-sterile manual surgical instrument that was distributed nationwide.
The recall was initiated because the Inserter Inner Shaft would not fit through the Inserter. The source text states that the inner diameter of the cannulated shaft of the inserter was undersized.
This recall affects healthcare facilities and providers who may have received these specific units. Users should stop using the affected instruments and contact Stryker Spine for further instructions.
The recalled product
- Product
- Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number 48590100. Manual Surgical Instrument.
- Manufacturer
- Stryker Spine
- Hazard
- Affected units
- 41
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 (3)
- Reference Number 48590100 Lots B40155
- B34446
- B34447 and B41171.
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Stryker Spine
See all →- HighStryker Spine Monterey AL Implant Inserter Recall Due to Potential Gold Button Separation
FDA (Devices) · 2025-04-09
- HighStryker Spine Monterey AL Implant Inserter Gold Unlock Button Separation Recall
FDA (Devices) · 2025-04-09
- HighStryker Monterey AL Implant Inserter Gold Button Detachment Risk
FDA (Devices) · 2025-04-09
- HighStryker Spine Monterey AL Implant Inserter Recalled for Potential Unlock Button Separation
FDA (Devices) · 2025-04-09
- ModerateAVS Anchor-C Cervical Cage Instructions for Use Labeling Correction
FDA (Devices) · 2024-10-02
Same hazard · mechanical defect
See all →- HighMobile Digital Radiographic System Arm Drop Risk During Patient Exams
FDA (Devices) · 2026-07-22
- ModerateSurgical driver systems recalled over out of the box driver wobble
FDA (Devices) · 2025-09-03
- HighBeckman Coulter DxI 9000 Analyzer wash wheel mixer defect may prevent operation
FDA (Devices) · 2025-03-19
- SevereBaxter Spectrum IQ Infusion System may have missing motor mounting screws
FDA (Devices) · 2025-03-12
- HighVNS Therapy Generator May Stop Delivering Stimulation Due to Mechanical Defect
FDA (Devices) · 2025-02-12