RegWardenFDA facility compliance records
Recall

Class II — Ebi, Llc

Recalling firmEBI, LLC - AHP EOS Buyer Inc.
Registered facilityView this company's 2 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonBroken screw insertor hardness was measured and found to be below the acceptable limits.
ProductBiomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178
Quantity15 units
DistributionNationwide Distribution, including the states of MO, TX, and IN.
Initiated2012-09-29
Classified2012-12-17
Terminated2015-12-07
Recall numberZ-0536-2013
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Ebi, Llc (Z-0536-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63653/

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