Biomet Spine, LLC: Medical Device Recall in 2015 - (Recall #: Z-2152-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 12, 2015

Date Posted: July 29, 2015

Recall Number: Z-2152-2015

Event ID: 70961

Reason for Recall:

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

Status: Terminated

Product Quantity: 4,765 units

Code Information:

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, 14-582250, 14-592320, 14-582325, 14-582330, 14-582335, 14-582340, 14-582345, 14-582350, 14-582530, 14-582535, 14-582540, 14-582545, 14-582550, 14-582565, 14-582570, 14-582575, 14-583020, 14-583025, 14-583030, 14-583035, 14-583040, 14-583120, 14-583125, 14-583130, 14-583135, 14-583140, 14-583220, 14-583225, 14-583230, 14-583235, 14-583240, 14-583245, 14-583250, 14-583320, 14-583325, 14-583330, 14-583335, 14-583340, 14-583345 and 14-583350. All lots.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated