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Arsenal Deformity Spinal Fixation System

ALPHATEC SPINE, INC. · Model 48700-030-095-035 · UDI-DI 00840967119656

MNI KWP OSH NKB NMH Prescription

510(k) clearances

3,989

Adverse events (17 deaths)

213

Recalls

343

Facilities

Description

ILIAC BOLT, 30 DEGREE, 9.5mm X 35mm

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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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.