Home › BM KOREA CO., LTD › SYNSTER (CERVICAL,ALIF, PLIF, PTLIF AND TLIF) CAGE HERA CERVICAL CAGE RHEA PLIF

SYNSTER (CERVICAL,ALIF, PLIF, PTLIF AND TLIF) CAGE HERA CERVICAL CAGE RHEA PLIF

BM KOREA CO., LTD · Model SPT1428 · UDI-DI 08809255540000

ODP MAX Prescription

510(k) clearances

1,117

Adverse events (3 deaths)

Recalls

344

Facilities

Description

The SYNSTER CERVICAL CAGE are indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

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.
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.
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.
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.
2020-09-30	XTANT Medical	Cervical Implants contain a label that incorrectly identifies the grade of titanium used.
2013-10-07	RTI Surgical, Inc.	As the result of a recent internal review of regulatory documents, we have determined that the 10 mm x 12 mm Webless C-Plus implants were incorrectly documented as meeting the requ
2013-02-05	SpineNet	The recall decision has been made because because it has recently been determined that the instructions for use (IFU) had certain statements that should have been removed prior to
2012-06-15	Exactech, Inc.	Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Inter
2011-09-23	Synthes USA (HQ), Inc.	LABELING CORRECTION - Following review of labeling and promotional materials associated with the Zero-P Implant system, it was found that the materials reference a study where PEEK

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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.