RegWardenFDA facility compliance records
Company

Arthrosurface, Inc.

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

Recalls by year

FDA actions on record by year2014: 2 recalls2’14’15’16’17’18’19’20’21’22’23’24’25’26
  • Recalls (2)

Registered facilities (1)

Recalls & enforcement

  • Class IITerminated2014-11-24
    Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
  • Class IITerminated2014-06-09
    An oversight in the implementation of the design change record resulted in outdated components being shipped to customers. The component did not pass a half-cycle sterilization.

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. “Arthrosurface, 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-9058162-arthrosurface-inc/

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