FDA Device Recalls

Class IICompleted

Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use environment includes anatomic pathology (AP) laboratories and histology facilities within hospital, clinic, reference, or private lab settings. The System is to be operated by qualified users in

Ventana Medical Systems Inc

The firm became aware of a cleaning solution leaking issue from the middle staining module of the Ventana HE 600 instrument, used for histologic section samples in anatomic pathology laboratory settings, which caused fluid to travel down to the electrical wiring connector of the Coverslipper solvent shield circuit board. This can cause an electrical short and result in burned components.

October 4, 2019 · DeviceView details →

Medtronic SynchroMed, Model A10

1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System

PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10

PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10

ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.

Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product Usage: It is intended to be used for interventional procedures, such as invasive cardiology, interventional radiology, and interventional neuroradiology.

Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B)

Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use environment includes anatomic pathology (AP) laboratories and histology facilities within hospital, clinic, reference, or private lab settings. The System is to be operated by qualified users in

iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System

CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H7mm, Part #018.1907.

CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H8mm, Part #018.1908.

CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308.