Think Surgical, Inc.: Orthopedic Stereotaxic Instrument
Recall Summary Think Surgical is recalling tracking array components used with its TMINI robotic system for knee replacement surgery because a knob on the device may loosen, potentially causing misalignment during surgery. The affected products are the TMINI Femur Tracking Array (REF 109003) and TMINI Tibia Tracking Array (REF 109004), which were distributed nationwide to surgical facilities. This is classified as a Class II recall, meaning the misalignment could result in improper placement of knee implants.
- Recalling firm
- Think Surgical, Inc.
- Product
- 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 for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components
- Reason
- Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-08
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/d300f810-b81d-4402-88c9-226593dd3674