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Malibu™
Seaspine Orthopedics Corporation · Model 17-0565 · UDI-DI 10889981028169
1
510(k) clearances
3,997
Adverse events (17 deaths)
213
Recalls
345
Facilities
Description
ANGLED HOOK, 5.5 X 6.5mm, LEFT. The Malibu system contains polyaxial screws of varying reduction height, cannulated polyaxial screws of varying reduction height, uniplanar screws of varying reduction height, monoaxial screws, iliac onoaxial screws, rods, rod connectors, screw spacers, crossbars, sublaminar wires and hooks. Implants are offered in a variety of lengths to accommodate variations in patient anatomy and are manufactured from Titanium 6Aluminum-4Vanadium ELI, with the exception of the Malibu and NewPort Cobaltt
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-18 | XTANT Medical Holdings, Inc | Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is. |
| 2023-07-12 | Medicrea International | There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. |
| 2018-07-05 | CTL Medical Corporation | the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during surgery, the anti-toggle ring can be pressed into the pedicle screw head and cause |
| 2017-06-21 | Valorem Surgical LLC | Devices are not consistent with Quality System Requirements. |
| 2017-06-21 | Valorem Surgical LLC | Devices are not consistent with Quality System Requirements. |
| 2017-06-21 | Valorem Surgical LLC | Devices are not consistent with Quality System Requirements. |
| 2017-06-21 | Valorem Surgical LLC | Devices are not consistent with Quality System Requirements. |
| 2017-06-21 | Valorem Surgical LLC | Devices are not consistent with Quality System Requirements. |
| 2017-06-21 | Valorem Surgical LLC | Devices are not consistent with Quality System Requirements. |
| 2017-06-21 | Valorem Surgical LLC | Devices are not consistent with Quality System Requirements. |
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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.