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
ReasonSeveral complaints were reported to exhibit screw head splay in the Cypher MIS Screw System.
ProductCypher 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
Quantity427 units
DistributionNationwide Distribution (US), including the states of IN, MD, MS, NC, OH, PA, SC, and TX.
Initiated2013-08-13
Classified2013-09-17
Terminated2015-03-11
Recall numberZ-2214-2013
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-2214-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66098/

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