FDA-Device2015-07-29Class II
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.
Biomet Spine, LLC
Hazard
Multiaxial screws may not meet internal requirements related to fatigue strength. Compression testing result and surface treatment are out of specification.
Sold states
Distribution US Nationwide (AL, CA, CO, FL, GA, LA, MA, MD, MI, MO, NY, OH, PA, TX, WA, WI) and The Netherlands.
Affected count
4,765 units
Manufactured in
399 Jefferson Rd, N/A, Parsippany, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2152-2015Don't want to check this manually?
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