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Facet Screw

ZYGOFIX LTD · Model 1 · UDI-DI 07290019421245

MRW Prescription

510(k) clearances

105

Adverse events

Recalls

103

Facilities

Description

The subjected screw is part of the zLOCK Lumbar Facet Fixation System. The zLOCK Lumbar Facet Fixation System is a modular facet screw system for posterior lumbar spinal stabilization. The zLOCK Lumbar Facet Fixation System consists of two main components: 1) a Facet Screw with a washer and 2) a Modular spacer. The system including a dedicated tool set.

Recalls

Date	Firm	Reason
2021-04-27	Medtronic Sofamor Danek USA, Inc	Product is impacted by a thread profile defect due to a manufacturing issue.
2011-06-07	Osteomed, Lp	Two of the Implant Driver Assembly tips were reported to break during surgery.
2011-03-15	Interventional Spine Inc	This recall has been initiated due to Pull Pins that may disengage from the Facet Screw during the compression step, requiring that compression be completed with a device driver ra
2011-03-15	Interventional Spine Inc	This recall has been initiated due to Pull Pins that may disengage from the Facet Screw during the compression step, requiring that compression be completed with a device driver ra

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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.