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INFINITY™ Occipitocervical Upper Thoracic System

MEDTRONIC SOFAMOR DANEK, INC. · Model 3654034 · UDI-DI 00763000991012

NKG Prescription

510(k) clearances

2,190

Adverse events (15 deaths)

Recalls

169

Facilities

Description

RMAS FT 3654034 3.5MM SCREW 4.0X34MM

Recalls

Date	Firm	Reason
2020-12-14	K2M, Inc	The Yukon polyaxial screw used in the Yukon Spinal System was incorrectly laser marked with size 5.0 mm (diameter) & 24 mm (length).
2020-11-03	K2M, Inc	Shafts do not pass through the inner cannula of the Anti-Torque Alignment Tube from Lot KTGG due to a manufacturing nonconformance. This could result in a delay of surgery or resul
2019-09-16	Synthes (USA) Products LLC	The subject product measures 4.0mm in diameter instead of 3.5mm.
2018-07-24	K2M, Inc	Screws had a manufacturing error that could prevent the screw from mating with the screw inserter or set screw as intended. This event was reported to FDA as part of Stryker's retr
2018-02-23	Orthofix, Inc	Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) with affected Lot Numbers 001 and 002, and Small Set Screw (PN: 79-2003) with affect
2018-02-23	Orthofix, Inc	Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) with affected Lot Numbers 001 and 002, and Small Set Screw (PN: 79-2003) with affect

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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.