Think Surgical recalls TMINI Femur and Tibia Tracking Arrays with specific UDI-DI codes due to a knob that may loosen, causing potential misalignment during knee replacement surgery. Affected units must be checked for the codes listed.
Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.
Think Surgical is recalling two surgical tracking arrays (Femur and Tibia) that may have a loose knob, which could cause misalignment during knee replacement surgery. This is a safety issue for surgeons using the devices in procedures.
The tracking arrays have a knob that may loosen during use, leading to potential misalignment of the surgical instruments. This could affect the accuracy of knee implant placement during total knee replacement procedures.
Surgeons and medical facilities using Think Surgical's TMINI Femur and Tibia Tracking Arrays with the specified UDI-DI codes for knee replacement surgery are affected. The risk is highest for those performing procedures with the recalled devices.
Check for the TMINI Femur Tracking Array REF 109003 with UDI-DI code M9461090030 or TMINI Tibia Tracking Array REF 109004 with UDI-DI code M9461090040. These are used in total knee replacement surgery.
Identify the UDI-DI code on your TMINI Femur or Tibia Tracking Array to confirm if it matches the recalled codes.
The recall is due to a manufacturing issue where the knob on the tracking array may loosen, causing potential misalignment during knee replacement surgery.
The official recall notice does not specify a remedy or action steps beyond checking the UDI-DI code. Affected users should contact Think Surgical for further guidance.
The recall notice states that misalignment could affect the accuracy of knee implant placement, but it does not specify patient injury risks.
We’ve drafted a message you can send Think Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-2716-2026 — Think Surgical Think Surgical Hello, I own a Think Surgical that is covered by recall Z-2716-2026 from Think Surgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
