The Recall Desk
HighFDA (Devices)·Z-2152-2015·Announced 2015-07-29

Biomet Polaris 4.75 TI Spinal System Multiaxial Screws Recalled for Fatigue Strength

Biomet Spine is recalling 4,765 units of Polaris 4.75 TI Spinal System multiaxial screws because they may not meet internal fatigue strength requirements.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (spinal fixation component) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Biomet Spine, LLC is recalling 4,765 units of the Polaris 4.75 TI Spinal System, specifically the 4.0 x 20 MM Closed Head Multiaxial Screw. The recall covers all lots of the affected part numbers, including 14-583020 and others listed in the agency record. These spinal fixation components were distributed nationwide in the United States to states including Alabama, California, Colorado, Florida, Georgia, Louisiana, Massachusetts, Maryland, Michigan, Missouri, New York, Ohio, Pennsylvania, Texas, Washington, and Wisconsin, as well as to The Netherlands.

The recall was initiated because the multiaxial screws may not meet internal requirements related to fatigue strength. Specifically, compression testing results and surface treatment were found to be out of specification. The source text does not report any illnesses, injuries, or deaths associated with these devices.

Healthcare providers and patients should contact Biomet Spine, LLC for further instructions on how to handle the recalled devices. The recall is classified as Class II by the FDA, indicating a reasonable probability that the device could cause temporary or medically reversible adverse health consequences.

The recalled product

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
Biomet Spine, LLC
Category
Medical Device — Spinal Fixation
Hazard
Affected units
4,765

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Part Numbers: 14-582020
  • 14-582022
  • 14-582025
  • 14-582030
  • 14-582035
  • 14-582040
  • 14-582120
  • 14-582122
  • 14-582125
  • 14-582127
  • 14-582130
  • 14-582135
  • 14-582140
  • 14-582220
  • 14-582222
  • 14-582225
  • 14-582230
  • 14-582235
  • 14-582240
  • 14-582245

Distribution

Distributed nationwide across the United States.

The notice also names 16 states specifically:

Related recalls

Same manufacturer · Biomet Spine, LLC

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