Z-2152-2015Class II

Polaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxial Screw, Non-Sterile, Rx Only...

Name: Z-2152-2015 Polaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxial Screw, Non-Sterile, Rx Only...
Creator: Biomet Spine, LLC
Published: 2015-03-12
License: https://open.fda.gov/license/

Highridge Medical, LLC / initiated 2015-03-12 / Terminated / root cause: manufacturing process

FDA source

Biomet Spine, LLC began a recall of 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... on 2015-03-12. FDA classified it as Class II and gives the reason as "Multiaxial screws may not meet internal requirements related to fatigue strength. Compression testing result and surface treatment are out of specification". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2152-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-12
Posted: 2015-07-20
Terminated: 2015-12-21
Recalling firm: Highridge Medical, LLC
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.
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: Multiaxial screws may not meet internal requirements related to fatigue strength. Compression testing result and surface treatment are out of specification.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Biomet Spine issued an Urgent Medical Device Recall Notice/Response Form dated 3/12/2015 to their affected customers.
Quantity in commerce: 4,765 units
Distribution: Distribution US Nationwide (AL, CA, CO, FL, GA, LA, MA, MD, MI, MO, NY, OH, PA, TX, WA, WI) and The Netherlands.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2152-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2152-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20

Product code NKB

K133746Class IIPolaris Spinal SystemBiomet Spine (Aka Ebi, LLC) / cleared 2014-03-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)