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 14-58302

Recalled July 29, 2015 · FDA recall Z-2152-2015 · Biomet Spine

Hazard

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

Units

4,765 units

Sold at

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

Description

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

Product

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.

Manufacturer(s)

Biomet Spine, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →