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Terminated

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.

FDA Recall Z-2152-2015 · Posted 2015-07-20

Recalling FirmBiomet Spine, LLC
Recall StatusTerminated
Product CodeNKB
Date Initiated2015-03-12
Date Terminated2015-12-21
Product Quantity4,765 units

Reason for Recall

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

Firm Action

Biomet Spine issued an Urgent Medical Device Recall Notice/Response Form dated 3/12/2015 to their affected customers.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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