CLASS II Device recall · Reported 27 Nov 2013 · FDA Enforcement Report

Biomet Spine, 5.5 TI 5.5x50mm Translation Screw Polaris recalled by Ebi

Ebi is recalling Biomet Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System, distributed nationwide in the US. The recall was initiated on 22 Aug 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMultiple Item and Lot numbers. The firm expects all Translation Screw Systems (containing a cobalt chrome component) used and contacted with the SpF Implantable Spine Fusion Stimulator (DC electrical current) to be at risk for this failure mode.

Quantity recalled7,092 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0359-2014
FDA event ID: 66300
Recalling firm: Ebi, Parsippany, NJ
Classification: Class II
Status: Terminated
Recall initiated: 22 Aug 2013
FDA classified: 19 Nov 2013
Reported: 27 Nov 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Spinal Implants

Timeline

22 Aug 2013	Recall initiated by company
19 Nov 2013	Classified by FDA	+89 days
27 Nov 2013	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Polaris Translation Screw Failures were recently reported to Biomet Spine. These failures are generally described as dissociation of the screw head from the shaft of the Polaris Translation Screw.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system

Where it was distributed

Nationwide distribution including Puerto Rico.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Polaris Translation Screw Failures were recently reported to Biomet Spine. These failures are generally described as dissociation of the screw head from the shaft of the Polaris Translation Screw.

Which lots are affected?

Multiple Item and Lot numbers. The firm expects all Translation Screw Systems (containing a cobalt chrome component) used and contacted with the SpF Implantable Spine Fusion Stimulator (DC electrical current) to be at risk for this failure mode.

Where was it sold?

Nationwide distribution including Puerto Rico.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Ebi

All 13

Reported	Class	Recall	Company	Reason	Where
1 May 2024Device	CLASS II	Biomet OrthoPak Non-invasive Bone Growth Stimulator recalled by EBI	EBI	Other	Nationwide
1 May 2024Device	CLASS II	20" Lead Wires, Replacement recalled by EBI	EBI	Other	Nationwide
1 May 2024Device	CLASS II	Biomet SpinalPak Non-invasive Spine Fusion Stimulator recalled by EBI	EBI	Other	Nationwide
1 May 2024Device	CLASS II	48" Lead Wires, Replacement recalled by EBI	EBI	Other	Nationwide
14 Jan 2015Device	CLASS II	Cypher MIS Screw System-The system includes screws recalled by Ebi	Ebi	Other	9 states

Other Spinal Implants recalls

All 1,157

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled	Avid Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: ENT recalled	Avid Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: A-P PACK recalled	Avid Medical	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide