The Recall Desk

Manufacturer

Ebi, Llc

13 recalls in our database name Ebi, Llc as the manufacturing or recalling firm.

What the numbers show

Total
13
Critical
0
Severe
0
Most recent
2024-05-01

Of the 13 recalls from Ebi, Llc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–13 of 13

  • HighFDA (Devices)·Z-1617-2024·2024-05-01

    Biomet OrthoPak Bone Growth Stimulator System Recalled Due to Lead Wire Damage

    The Biomet OrthoPak Bone Growth Stimulator System is being recalled due to potential lead wire sheath damage that could prevent therapeutic signal delivery and delay patient treatment nationwide.

    Product
    Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. Part Number: 1067718
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1618-2024·2024-05-01

    Replacement Lead Wires Recalled for Risk of Treatment Delivery Failure

    EBI, LLC recalls 829 replacement lead wire assemblies (Part 1067724-2) distributed nationwide since May 1, 2023. Damaged wire sheaths may prevent therapeutic treatment signals from reaching electrodes, potentially delaying treatment.

    Product
    20" Lead Wires, Replacement Part Number: 1067724-2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1616-2024·2024-05-01

    Spine Fusion Stimulator Recalled for Damaged Lead Wire Sheath

    The Biomet SpinalPak Spine Fusion Stimulator System is recalled for potential lead wire sheath damage that may prevent delivery of the therapeutic treatment signal. Devices distributed nationwide since May 2023 are affected.

    Product
    Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, Part Number: 1067716
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1619-2024·2024-05-01

    Lead Wire Replacement Parts Recalled for Sheath Damage and Treatment Signal Loss

    EBI, LLC is recalling 594 units of 48-inch lead wire replacement parts (part number 1067724-4) due to sheath damage that prevents therapeutic signals from reaching treatment electrodes.

    Product
    48" Lead Wires, Replacement Part Number: 1067724-4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0909-2015·2015-01-14

    Ebi Recalls Cypher MIS Screw System Due to Inoperative Screw Heads

    Ebi, LLC is recalling the Cypher MIS Screw System because screw heads may splay or fracture, rendering the device inoperative.

    Product
    Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws. Various instruments are also available for use by the surgeon to facilitate implantation of the device. Non-cervical spinal fixation device intended for immobilization and sta
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0874-2015·2014-12-31

    Ebi Solitaire-C Cervical Spacer Drill Sleeves Recalled for Design Deficiency

    Ebi, LLC is recalling 193 units of Solitaire-C Cervical Spacer System drill sleeves because a design defect allows instruments to penetrate 1.0 mm beyond intended depths.

    Product
    Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594 Spring-Loaded Drill/Awl Sleeve Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1811-2014·2014-06-25

    Biomet Spine Cypher MIS Screw Inserter Recalled for Tip Failure

    Ebi, LLC is recalling 32 units of the Biomet Spine Cypher MIS Screw Inserter due to an increased rate of instrument tip failure.

    Product
    Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0411-2014·2013-12-04

    Biomet Recalls Shortened Plug Driver Due to Instrument Tip Shearing

    Biomet is recalling two units of a Shortened Plug Driver after a complaint reported the instrument tip sheared off during a surgical removal case.

    Product
    Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ 07054 The Polaris Spinal Systems is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedical screw fixa
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0359-2014·2013-11-27

    Biomet Spine Recalls Polaris Translation Screws Due to Head Dissociation

    Biomet Spine is recalling 7,092 Polaris Translation Screws because the screw head may separate from the shaft. The recall covers nationwide distribution including Puerto Rico.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2292-2013·2013-10-09

    Ebi Solitaire-35 Spinal Fusion Device Recalled for Screw Complaints

    Ebi, LLC is recalling 1,730 units of the Solitaire-35 PEAK Solitaire Anterior Spinal System due to complaints regarding one of the three screws driving through the cage.

    Product
    Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2214-2013·2013-09-25

    Ebi Recalls Cypher MIS Screw System Due to Screw Head Splay

    Ebi, LLC is recalling 427 units of the Cypher MIS Screw System because several complaints reported screw head splay.

    Product
    Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cervical spinal fixation device. 1)Screw Tower - REF 14-501660 2) Rod Reduce - REF 14-501661 3) Counter Torque - REF 14-501662
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0954-2013·2013-03-27

    Biomet Spine Polaris Screw Inserter Recalled for Tip Failure Risk

    Ebi, LLC is recalling 59 units of the Biomet Spine Polaris 5.5 Button Lock Screw Inserter due to an increased risk of failure at the driver tip during use.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0536-2013·2012-12-26

    Biomet Polaris 5.5 Button Lock Screw Inserter Recalled for Hardness Defect

    Ebi, LLC is recalling 15 units of Biomet Polaris 5.5 Button Lock Screw Inserters because the hardness of broken units was found to be below acceptable limits.

    Product
    Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178
    Category
    Medical Device
    Distribution
    Distributed nationwide