Why 4 spine and orthopedic products were recalled in the last 18 months

Spinal Tech

Three spine and orthopedic products were recalled since 2020, including a spinal allograft and scoliosis system.

Here's what you should know about the cases:

Aziyo Biologics
Aziyo Biologics voluntarily recalled a lot of its FiberCel allograft June 2 after several patients who received it tested positive for tuberculosis. The infected lot had 154 units from one donor and was distributed to facilities in 20 states.

Lawsuits have been filed on behalf of some patients who were sickened by the tainted allografts in the past month. Among them are a Florida woman and two men from Delaware.

Aziyo Biologics is working with the FDA and CDC to investigate the implants, according to a spokesperson.

"We have reviewed our procedure for screening donors and producing this product and have not identified any deviations from our established protocols, which are based on industry standards and government requirements," according to a statement provided to Becker's Spine Review. "We are evaluating adjustments to our donor screening and testing methodology and process to broaden detection of disease beyond existing industry standards."

Zimmer Biomet
Zimmer Biomet recalled a batch of orthopedic implants in Europe in April 2020. It applied to polyethylene implants with potentially elevated endotoxin levels. A routine bacterial endotoxin testing of polyethylene implants found three samples exceed accepted standards for endotoxin levels during a six-week period.

The company didn't receive any complaints related to the recall.

NuVasive issued an urgent field safety notice Feb. 13, 2020, to recall its Magec System Model X rods. The system braces the spine during growth to minimize the progression of scoliosis. It was under investigation after separation of an actuator end cap component was reported in 0.5 percent of Magec devices post-implantation.

In December 2020, NuVasive said issues with the Magec system can manifest in vivo as locking pin breakage, O-ring seal failure, generation of metal wear debris and failure of the rod to distract.

A company statement on Magec posted in April 2021 said CE certification for Magec products was temporarily suspended, and sales in countries requiring a CE mark are on hold.

Medtronic withdrew its Infuse Bone Graft/LT-Cage Lumbar Tapered Fusion device from the Australian market in March 2020. An investigation found spine surgeons were using the product "off label," and a whistleblower said the device was being used in unapproved ways without the cage designed to contain it.

Medtronic told Becker's Spine Review:

"The decision to withdraw is not related to product safety — nor is it taken lightly given the potential impact upon patients. The [Therapeutic Goods Administration] has been consulted regarding the withdrawal and are aware of our intent to seek approval to make Infuse Bone Graft available in future in Australia, taking into account local clinical practice …. We continue to invest in prospective clinical trials globally with the goal of expanding indications for safe and effective use of the product worldwide."


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