5 spine, neurosurgery devices recalled in 2019

Written by Alan Condon | December 11, 2019 | Print  |

Here are five spine and neurosurgical devices recalled by the FDA in 2019.

Johnson & Johnson's DePuy Synthes voluntarily recalled its USS II Polyaxial 3D heads, according to an urgent field safety notice issued out of Switzerland in November. The devices are part of the USS II Polyaxial System, a posterior pedicle screw fixation system designed to provide spine stabilization in skeletally mature patients, and not available in the U.S.

Zimmer Biomet recalled the ROSA Brain 3.0 Robotic Surgery System in November due to a software issue that can drive the robotic arm to an incorrect position. Zimmer Biomet received five complaints related to the issue, including one patient injury. No deaths related to this issue were reported.

Alpha Omega Engineering's Neuro Omega system, used to assist neurosurgeons in identifying brain structures during neurosurgery, was recalled in May due to a design flaw that may fuse two separate electrode stimulation channels into one. The flaw, causing unplanned electrical stimulation, could cause significant harm to a patient's brain tissue. No patient injuries or deaths were reported.

In April, Brainlab recalled its Spine & Trauma 3D Navigation Software due to the potential for incorrect information to display during surgery, which may prevent the surgeon from accurately navigating tools inside the patient. The flaw could result in a second surgical procedure, life-threatening patient injuries or death.

Medtronic recalled the Synergy Cranial Software and StealthStation S7 Cranial Software used with the StealthStation Surgical Navigation System in January. The recall was due to reports of incorrect information displaying during biopsy procedures that could result in serious or life-threatening patient harm. The software defect could affect the neurosurgeon and have them insert the surgical tool too deeply and damage the patient's healthy tissue, brain or blood vessels.

More articles on devices:
Dr. Tony Mork: Reimbursement, lack of training shackles progress of endoscopic spine surgery
Neurosurgeon Dr. Griff Harsh joins ownership group of MLS franchise
DePuy Synthes recalls devices used in spine fixation system: 6 things to know

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