Home › Wenzel Spine, Inc. › VariLift-L

VariLift-L

Wenzel Spine, Inc. · Model CIE2-11-24-00 · UDI-DI 00813210020009

MAX Prescription

510(k) clearances

9,238

Adverse events (30 deaths)

115

Recalls

422

Facilities

Description

The Wenzel Spine VariLift Lumbar Interbody Fusion Device is a self-tapping, expandable device with an interior sliding wedge and a posterior end cap. The VariLift-L is a grooved and fluted device with large graft windows positioned each of its four quadrants that provide bony contact with the endplates. VariLift-L is designed to be implanted bi-laterally via posterior (PLIF) approach or as a single device via a transverse (TLIF) approach. VariLift-L may be implanted with or without supplemental fixation and is intended for use with autograft to facilitate fusion. VariLift-L is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

Recalls

Date	Firm	Reason
2025-11-03	Orthofix U.S. LLC	Labeling contains claims that are not consistently present.
2025-11-03	Orthofix U.S. LLC	Labeling contains claims that are not consistently present.
2025-10-29	Medicrea International	Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
2025-10-29	Medicrea International	Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
2025-09-16	Medtronic Sofamor Danek USA Inc	Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical techni
2025-08-06	SEASPINE ORTHOPEDICS CORPORATION	Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant positioning, which may may le
2025-06-24	Orthofix U.S. LLC	A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap infor
2025-02-20	Orthofix U.S. LLC	The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm.
2024-12-15	Alphatec Spine, Inc.	Complaints have been received regarding post-operative implant collapse.
2024-08-14	Innovasis, Inc	Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.