RegWardenFDA facility compliance records
Company

ALTO DEVELOPMENT CORP.

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

Recalls by year

FDA actions on record by year2017: 1 recalls; 2019: 2 recalls120172018220192020202120222023202420252026
  • Recalls (3)

Registered facilities (1)

Recalls & enforcement

  • Class IITerminated2019-09-10
    Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensioner inoperable.
  • Class IITerminated2019-06-21
    Updated instructions for use: Ultra-Flex MYO/WIRE Monopolar pacing wire looped electrode (M-21 Series) to be consistent between electrode IFU and instructions for M-21 loop.
  • Class IITerminated2017-10-23
    Surgical punches are being recalled due to potential packaging damage which may have occurred during transportation resulting in loss of sterility.

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. “ALTO DEVELOPMENT CORP. — 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-2242056-alto-development-corp/

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