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CORRIDOR

GLOBUS MEDICAL, INC. · Model 148.430 · UDI-DI 00849044033366

MRW
1
510(k) clearances
105
Adverse events
4
Recalls
100
Facilities

Description

4.5mm Bone Screw, 30mm

Recalls

DateFirmReason
2021-04-27Medtronic Sofamor Danek USA, IncProduct is impacted by a thread profile defect due to a manufacturing issue.
2011-06-07Osteomed, LpTwo of the Implant Driver Assembly tips were reported to break during surgery.
2011-03-15Interventional Spine IncThis 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
2011-03-15Interventional Spine IncThis 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.