Virata TL1-10785050Recalls & reported problems

Seaspine Orthopedics Corporation · Polyaxial Screw, CC, 8.5mm X 50mm · Class 2 · Implant

All models of Virata (25)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

Sep 19, 2025Class IIOpen, Classified
Polyaxial screws do not meet performance standards.
Z-0478-2026 · Root cause: Process change control · Recall details · FDA record ↗

Device details

UDI-DI	`10889981335847`
Brand	Virata
Model	TL1-10785050
Company	Seaspine Orthopedics Corporation
Product code	NKB · Thoracolumbosacral pedicle screw system
Class	Class 2
FDA submission	K250908
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 29, 2025

Device type (GMDN): Spinal bone screw, non-bioabsorbable

A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

Other Thoracolumbosacral pedicle screw system devices

EXPEDIUM VERSE 199721000
Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease
387 reports
Sequoia® 3301-1
Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease
184 reports
CD HORIZON® Spinal System 8590855
Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease
179 reports
Vitality® 07.02011.001
Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease
3 recalls0 reports
EXPEDIUM VERSE 199721001S
Medos International Sàrl · Thoracolumbosacral pedicle screw system
124 reports
LineSider LS-N6SA7550
Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System
2 recalls1 report
LineSider LS-N6SA6545
Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System
2 recalls0 reports
EXPEDIUM VERSE 199721000S
Medos International Sàrl · Thoracolumbosacral pedicle screw system
97 reports

All Thoracolumbosacral pedicle screw system devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page