RegWardenFDA facility compliance records
Company

ATLAS SPINE INC.

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

Recalls by year

FDA actions on record by year2009: 1 recalls; 2013: 1 recalls1’09’10’11’121’13’14’15’16’17’18’19’20’21’22’23’24’25’26
  • Recalls (2)

Registered facilities (1)

Recalls & enforcement

  • Class IITerminated2013-07-26
    The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space.
  • Class IITerminated2009-06-04
    Atlas Spine, Inc. recalled their Apelo Modular Screwdriver, a component of the Apelo Pedicle Screw System Instrumentation, because of complaints received about the tip breaking. If the tip is fractured inside of the modular screw, the tip could become implanted in the body or if …

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. “ATLAS SPINE 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-9053705-atlas-spine-inc/

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