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Valorem Surgical Recalls

144 recalls on record · August 16, 2017 to August 16, 2017 · Medical Devices

August 16, 2017Medical DevicesFDA
Valorem Surgical LLC recalls PALLAS M/MAXIMIS Closed Extension. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL.
Hazard: Devices are not consistent with Quality System Requirements.
August 16, 2017Medical DevicesFDA
Valorem Surgical LLC recalls PALLAS M/MAXIMIS Open Extension (Large). Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicag
Hazard: Devices are not consistent with Quality System Requirements.
August 16, 2017Medical DevicesFDA
Valorem Surgical LLC recalls PALLAS M/MAXIMIS Open Extension (Small). Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicag
Hazard: Devices are not consistent with Quality System Requirements.
August 16, 2017Medical DevicesFDA
Valorem Surgical LLC recalls PALLAS M/MAXIMIS MIS Tapper 6.5mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL.
Hazard: Devices are not consistent with Quality System Requirements.
August 16, 2017Medical DevicesFDA
Valorem Surgical LLC recalls PALLAS M/MAXIMIS MIS Tapper 5.5mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL.
Hazard: Devices are not consistent with Quality System Requirements.
August 16, 2017Medical DevicesFDA
Valorem Surgical LLC recalls PALLAS M/MAXIMIS MIS Pedicle Cut. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL.
Hazard: Devices are not consistent with Quality System Requirements.
August 16, 2017Medical DevicesFDA
Valorem Surgical LLC recalls PALLAS M/MAXIMIS Dilator B. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Produ
Hazard: Devices are not consistent with Quality System Requirements.
August 16, 2017Medical DevicesFDA
Valorem Surgical LLC recalls PALLAS M/MAXIMIS Dilator A. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Produ
Hazard: Devices are not consistent with Quality System Requirements.
August 16, 2017Medical DevicesFDA
Valorem Surgical LLC recalls PALLAS M/MAXIMIS Dilator Handle. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL.
Hazard: Devices are not consistent with Quality System Requirements.
August 16, 2017Medical DevicesFDA
Valorem Surgical LLC recalls PALLAS M/MAXIMIS Cross Link Torque Handle. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chic
Hazard: Devices are not consistent with Quality System Requirements.
August 16, 2017Medical DevicesFDA
Valorem Surgical LLC recalls PALLAS M/MAXIMIS Reduction B. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Pro
Hazard: Devices are not consistent with Quality System Requirements.
August 16, 2017Medical DevicesFDA
Valorem Surgical LLC recalls PALLAS M/MAXIMIS Reduction A. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Pro
Hazard: Devices are not consistent with Quality System Requirements.
August 16, 2017Medical DevicesFDA
Valorem Surgical LLC recalls PALLAS M/MAXIMIS Inside Bender (L) and (R). Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chi
Hazard: Devices are not consistent with Quality System Requirements.
August 16, 2017Medical DevicesFDA
Valorem Surgical LLC recalls PALLAS M/MAXIMIS Marking Pin (Round Jaw). Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chica
Hazard: Devices are not consistent with Quality System Requirements.
August 16, 2017Medical DevicesFDA
Valorem Surgical LLC recalls PALLAS M/MAXIMIS Marking Pin (Smooth). Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago,
Hazard: Devices are not consistent with Quality System Requirements.
August 16, 2017Medical DevicesFDA
Valorem Surgical LLC recalls PALLAS M/MAXIMIS Distractor. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Prod
Hazard: Devices are not consistent with Quality System Requirements.
August 16, 2017Medical DevicesFDA
Valorem Surgical LLC recalls PALLAS M/MAXIMIS Compressor. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Prod
Hazard: Devices are not consistent with Quality System Requirements.
August 16, 2017Medical DevicesFDA
Valorem Surgical LLC recalls PALLAS M/MAXIMIS Rod Bender. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Prod
Hazard: Devices are not consistent with Quality System Requirements.
August 16, 2017Medical DevicesFDA
Valorem Surgical LLC recalls PALLAS M/MAXIMIS Anti Torque. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Pro
Hazard: Devices are not consistent with Quality System Requirements.
August 16, 2017Medical DevicesFDA
Valorem Surgical LLC recalls PALLAS M/MAXIMIS Rod Holder. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Prod
Hazard: Devices are not consistent with Quality System Requirements.
August 16, 2017Medical DevicesFDA
Valorem Surgical LLC recalls PALLAS M/MAXIMIS Nut Driver 4.0 Hexa and Alignment Driver. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valore
Hazard: Devices are not consistent with Quality System Requirements.
August 16, 2017Medical DevicesFDA
Valorem Surgical LLC recalls PALLAS M/MAXIMIS Poly Screw Driver. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL
Hazard: Devices are not consistent with Quality System Requirements.
August 16, 2017Medical DevicesFDA
Valorem Surgical LLC recalls PALLAS M/MAXIMIS Wall Check. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Prod
Hazard: Devices are not consistent with Quality System Requirements.
August 16, 2017Medical DevicesFDA
Valorem Surgical LLC recalls PALLAS M/MAXIMIS Tapper 6.5. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Prod
Hazard: Devices are not consistent with Quality System Requirements.
August 16, 2017Medical DevicesFDA
Valorem Surgical LLC recalls PALLAS M/MAXIMIS Tapper 5.5. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Prod
Hazard: Devices are not consistent with Quality System Requirements.
August 16, 2017Medical DevicesFDA
Valorem Surgical LLC recalls PALLAS M/MAXIMIS Awl. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product lab
Hazard: Devices are not consistent with Quality System Requirements.
August 16, 2017Medical DevicesFDA
Valorem Surgical LLC recalls PALLAS M/MAXIMIS 500mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, I
Hazard: Devices are not consistent with Quality System Requirements.
August 16, 2017Medical DevicesFDA
Valorem Surgical LLC recalls PALLAS M/MAXIMIS 400mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, I
Hazard: Devices are not consistent with Quality System Requirements.
August 16, 2017Medical DevicesFDA
Valorem Surgical LLC recalls PALLAS M/MAXIMIS 350 Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL.
Hazard: Devices are not consistent with Quality System Requirements.
August 16, 2017Medical DevicesFDA
Valorem Surgical LLC recalls PALLAS M/MAXIMIS 40mm Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Produc
Hazard: Devices are not consistent with Quality System Requirements.