Home › Life Spine, Inc. › Plateau-X Spacer System
Plateau-X Spacer System
Life Spine, Inc. · Model 2016-0187 · UDI-DI 00190837059897
MAX
Prescription
1
510(k) clearances
9,183
Adverse events (30 deaths)
115
Recalls
422
Facilities
Description
Plateau- LO 10mm x 36mm x 8mm, 7 degree, Modified Hudson Tri
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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Get your free API keyRead the docsData 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.