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ZYFUSE

GLOBUS MEDICAL, INC. · Model 147.630S · UDI-DI 00889095334166

MRW

510(k) clearances

105

Adverse events

Recalls

100

Facilities

Description

ZyFuse HA Compression Screw, 6mm x 30mm

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.