OrthoBuzz occasionally receives posts from guest bloggers. In response to a recent “safety communication” from the FDA, the following commentary comes from Ariel Palanca, MD; Adam Bitterman, DO: and Christopher
Tag: FDA
There are 15 references to JBJS studies in the recently published 149-page white paper on “Biological Responses to Metal Implants,” from the FDA’s Center for
The US FDA has approved the Synovasure Alpha Defensin Lateral Flow Test Kit for helping detect periprosthetic joint infection (PJI) in the synovial fluid of
Brainlab AG is recalling its Spine & Trauma 3D Navigation software (version 1.0). The FDA has identified this as a Class I recall, the agency’s
We have entered an era where total ankle arthroplasty (TAA) is accepted as a rational approach for patients with degenerative arthritis of the ankle. TAA
The July 6, 2016, edition of The Journal of Bone & Joint Surgery features a large case-cohort study that may help older patients and clinicians
BMJ recently published two studies of interest to orthopaedists: After analyzing data from more than 200 cardiovascular, orthopaedic, and neurologic devices approved in both the
Most orthopaedic devices are cleared through the FDA’s 510(k) process. But an analysis in the March 16, 2016 JBJS by Day et al. revealed that
What happens when hospital-specified, -purchased, and -owned equipment fails? How is information about such failures distributed within the hospital and to the orthopaedic community at
In late April, the FDA issued a safety announcement cautioning that corticosteroids delivered by epidural injection to treat back and neck pain may cause “rare