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APEX Spine System

SPINECRAFT, LLC · Model MR6-5560C · UDI-DI 00193082010576

KWQ NKB MNH MNI KWP Prescription

510(k) clearances

10,554

Adverse events (59 deaths)

214

Recalls

359

Facilities

Description

APEX Ti Cannulated Mono Reduction Screw Dia.5.50, 60mm

Recalls

Date	Firm	Reason
2026-02-20	Clariance-SAS	Due to a quality issue regarding the presence of burr on the finished cervical plate product.
2021-04-26	Alphatec Spine, Inc.	There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
2021-04-26	Alphatec Spine, Inc.	There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
2021-04-26	Alphatec Spine, Inc.	There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
2021-04-26	Alphatec Spine, Inc.	There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
2021-04-26	Alphatec Spine, Inc.	There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
2021-04-26	Alphatec Spine, Inc.	There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
2021-04-26	Alphatec Spine, Inc.	There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
2021-04-26	Alphatec Spine, Inc.	There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
2021-04-26	Alphatec Spine, Inc.	There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.

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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.