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Vu a-POD™

Seaspine Orthopedics Corporation · Model 21-11-3512 · UDI-DI 10889981037802

OVD Prescription

510(k) clearances

1,268

Adverse events (11 deaths)

Recalls

254

Facilities

Description

35x27 12mm Spin Plate. The Vu a-POD intervertebral body fusion device is comprised of polymer (PEEK OPTIMA® LT) concave cages. The PEEK cages include tantalumpins (or radiopaque markers) for radiological evaluation. All pins are press fit into the PEEK material. The pins are placed in the implant on each end of the PEEK cages to allow easier radiological assessment of the position and orientation of the radiolucent PEEK cage.

Recalls

Date	Firm	Reason
2026-04-23	Novapproach Spine, LLC	Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to securely engage the implant with the inserter,
2025-11-03	Orthofix U.S. LLC	Labeling contains claims that are not consistently present.
2025-02-28	Stryker Spine	Potential for the gold unlock button to separate from the inserter.
2025-02-28	Stryker Spine	Potential for the gold unlock button to separate from the inserter.
2025-02-28	Stryker Spine	Potential for the gold unlock button to separate from the inserter.
2025-02-28	Stryker Spine	Potential for the gold unlock button to separate from the inserter.
2025-01-03	XTANT Medical Holdings, Inc	Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.
2024-07-15	Omnia Medical	Failure of fusion system instruments in the field.
2024-07-15	Omnia Medical	Failure of fusion system instruments in the field.
2024-01-26	Alphatec Spine, Inc.	Due to reports of intraoperative graft bolt implantation breakages.

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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.