RegWardenFDA facility compliance records
Company

EBI, LLC - AHP EOS Buyer Inc.

10 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2012: 1 recalls; 2013: 5 recalls; 2014: 3 recalls; 2024: 1 recalls1’125’133’14’15’16’17’18’19’20’21’22’231’24’25’26
  • Recalls (10)

Registered facilities (2)

Recalls & enforcement

  • Class IIOngoing2024-03-22
    Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
  • Class IITerminated2014-11-11
    A design deficiency was discovered whereby the Drill/Awl Sleeve and Spring-Loaded Drill/Awl Sleeve instruments (the Sleeves) allow the mating Drill and Awl instruments to penetrate 1.0 mm beyond their intended depths during screw hole preparation.
  • Class IITerminated2014-10-08
    Inoperative screw head seat splay and/or fracture as a result of positioning of the rod which is a part of the Cypher MIS Screw System.
  • Class IITerminated2014-05-15
    The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure.
  • Class IITerminated2013-09-24
    Biomet received a complaint on 5/20/2013 reporting that the tip of the instrument sheared off during a removal case.
  • Class IITerminated2013-08-22
    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.
  • Class IITerminated2013-08-13
    Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System.
  • Class IITerminated2013-04-09
    Several complaints were recorded regarding one of the three screws driving through the cage of the Solitaire 35 implant.
  • Class IITerminated2013-02-07
    Increased risk of failure at the driver tip during screw insertion or removal.
  • Class IITerminated2012-09-29
    Broken screw insertor hardness was measured and found to be below the acceptable limits.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “EBI, LLC - AHP EOS Buyer Inc. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-2242816-ebi-llc-ahp-eos-buyer-inc/

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