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Indus

SPINEFRONTIER, INC. · Model 01-71013-55 · UDI-DI 00190361035596

KWQ Prescription

510(k) clearances

10,554

Adverse events (59 deaths)

214

Recalls

359

Facilities

Description

Indus Invue MAX Symmetrical ACP, 2 Level, 57mm

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.