2 device recalls in spine, neurosurgery

Spinal Tech

A prominent surgical robot and a spinal allograft were among the products that have been recalled by medical device companies in the past year:

Zimmer Biomet (Rosa One 3.1 brain application)

Zimmer Biomet recalled its Rosa One 3.1 brain application in September because of a software error that could lead to the misplacement of instruments during neurosurgical procedures.

The software issue could affect techniques that direct surgical tools using coordinates provided by medical imaging to reach a specific part of the brain. If this occurs, it could cause adverse events such as stroke, severe injury, disability or death, according to the FDA.

Corrective updates to the system are expected to be ready for installation by February 2022, with all updates completed by May. The FDA said that 119 devices have been recalled in the U.S.

Aziyo Biologics (FiberCel)

Aziyo Biologics in June voluntarily recalled one lot of its FiberCel product — a bone matrix allograft to promote bone growth in spine surgery — after several patients who received it tested positive for tuberculosis.

Multiple lawsuits were filed on behalf of patients who allegedly were sickened or died from a tainted product. In October, Medtronic terminated its deal to distribute Aziyo Biologics' bone matrix products.

Aziyo Biologics is working with the FDA and CDC to investigate the implants.

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