Polaris 4 recalled over sterility concerns

Recall date

March 12, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Biomet Spine, LLC recalls Polaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxial Screw, Non-Sterile, Rx Only, REF 14-5830…

Recall number

Z-2152-2015

FDA classification

Class II

Brand / firm

Biomet Spine, LLC

Sold / distributed

Distribution US Nationwide (AL, CA, CO, FL, GA, LA, MA, MD, MI, MO, NY, OH, PA, TX, WA, WI) and The Netherlands.

Why it was recalled

Multiaxial screws may not meet internal requirements related to fatigue strength. Compression testing result and surface treatment are out of specification.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Polaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxial Screw, Non-Sterile, Rx Only, REF 14-583020, Biomet Spine and Bone Healing Technologies. Spinal fixation component.