Fremont, CA, United States
Think Surgical, Inc. recalls
3 recalls recorded since 2018, most recently on 8 May 2026. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)2
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 8 May 2026
- Reason
- Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.
- Distribution
- U.S. Nationwide distribution in the states of AZ, CA, DE, FL, IA, KS, LA, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OR, PA, TX, UT, VA, and WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2716-2026
- TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking Array REF 109004 UDI-DI code: M9461090040 TMINI Miniature Robotic System is indicated as a stereotaxic instrumentation system fo
Ongoing Class II Medical devices
- Recall started
- 12 February 2024
- Reason
- 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 guide has the possibility of binding to the array fixation pins during drilling.
- Distribution
- US Nationwide distribution in the states of AL, OH, NV, TX, UT, CA, MO.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1318-2024
- Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic System
Terminated Class II Medical devices
- Recall started
- 30 March 2018
- Terminated
- 24 January 2020
- Reason
- There is a potential for the cutter head to detach from the cutter shaft.
- Distribution
- The devices were distributed to the following US states: NJ, NY, OH, and TX. The devices were also distributed to Korea.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2605-2018
- Think Surgical Cutter, Flat, ¿6.2mm x 144mm. For use only with the TCAT Computer-Assisted Tool. Part Number 106428 The cutter is used to prepare the bone for the (TKA) Total Knee Arthroplasty.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.