RegWardenFDA facility compliance records
Company

Think Surgical Inc.

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

Recalls by year

FDA actions on record by year2018: 1 recalls; 2024: 1 recalls; 2026: 1 recalls2017120182019202020212022202312024202512026
  • Recalls (3)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2026-05-08
    Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.
  • Class IIOngoing2024-02-12
    There is a galling effect (cold-weld) caused by friction between the array fixation pins and the TMINI array guide holes due to insufficient clearance between the outer diameter of the fixation pins and the inner diameter of the TMINI array guide holes. As a result, the array gui…
  • Class IITerminated2018-03-30
    There is a potential for the cutter head to detach from the cutter shaft.

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. “Think Surgical 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-10028805-think-surgical-inc/

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