RegWardenFDA facility compliance records
Company

BIOHORIZONS IMPLANT SYSTEMS, INC.

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

Recalls by year

FDA actions on record by year2012: 1 recalls; 2013: 1 recalls; 2015: 2 recalls1’121’13’142’15’16’17’18’19’20’21’22’23’24’25’26
  • Recalls (4)

Registered facilities (1)

Recalls & enforcement

  • Class IITerminated2015-10-30
    An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging.
  • Class IITerminated2015-04-16
    BioHorizons Tapered HD Upgrade set was packaged with an incorrect drill component manufactured of stainless steel in place of the correct component manufactured from titanium.
  • Class IITerminated2013-12-10
    The body length of the External Implant 40105D3 Lot 1302762 labeled as 10.5mm in length is in fact 12mm in length.
  • Class IITerminated2012-11-19
    The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use.

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. “BIOHORIZONS IMPLANT SYSTEMS, 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-9024113-biohorizons-implant-systems-inc/

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