Device recall: Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-cervic

FDA enforcement event 64452 · Class II · initiated 7 Feb 2013 · status Terminated · terminated 7 Dec 2015

DeviceVoluntary: Firm initiated1 product recordParsippany, NJ

Ebi, Llc (Parsippany, NJ) initiated this device recall on 7 Feb 2013; FDA lists 1 product record under event 64452, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.

Status: Terminated, terminated 7 Dec 2015. Initiation: voluntary: firm initiated. Ebi, Llc has 10 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Ebi, Llc, Parsippany, NJ.

Reason for recall

"Increased risk of failure at the driver tip during screw insertion or removal."

Distribution

"Nationwide Distribution including the states of AL, IN, MO, NE TN and TX."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0954-2013	Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-cervical, pedicle screw spinal fixation device.	59 units.	Class II	Terminated	27 Mar 2013

Context

90%of 2013 device events are Class II1,236 events that year

1product record in this eventfirm median: 1

10events on this register for the firm

Other enforcement events for Ebi, Llc

Initiated	Product (first record)	Type	Class	Records
22 Mar 2024	Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion acq	Device	Class II	4
11 Nov 2014	Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594 Spring-Loaded Drill/Awl Sleeve Intended to	Device	Class II	1
8 Oct 2014	Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws. Various instruments	Device	Class II	1
15 May 2014	Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System.	Device	Class II	1
24 Sep 2013	Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ 07054 The	Device	Class II	1
22 Aug 2013	BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. Intended for immobil	Device	Class II	1
13 Aug 2013	Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cervical spinal fixatio	Device	Class II	1
9 Apr 2013	Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device.	Device	Class II	1
29 Sep 2012	Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178	Device	Class II	1

All 10 events for Ebi, Llc

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Increased risk of failure at the driver tip during screw insertion or removal."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide Distribution including the states of AL, IN, MO, NE TN and TX."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 7 Dec 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.