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Integra Expandable Interbody

Seaspine Orthopedics Corporation · Model 82-3008 · UDI-DI 10889981049331

MAX Prescription

510(k) clearances

9,183

Adverse events (30 deaths)

115

Recalls

422

Facilities

Description

IMPLANT, 30mm LG, 8-12mm HT, 10mm WD, 0 DEG. The Integra Expandable IBD System consists of lumbar interbody fusion devices manufactured from PEEK-OPTIMA® LT1 (ASYM F2026), titanium (Ti-6AI-4V ELI per ASTM F136) and cobalt chromium (Co-28Cr-6Mo per ASTM F1537) materials, with radiopaque tantalum markers (ASTM F560).

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.

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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.