Think Surgical TMINI Tracking Arrays: Risk of Misalignment Due to Loose Knob
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.
Use caution until it’s fixed
Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/49197-think-surgical-tmini-tracking-arrays-risk-of-misalignment-due-to.
Source Summary by GovInfoNow · govinfonow.com/recall/49197-think-surgical-tmini-tracking-arrays-risk-of-misalignment-due-to · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2716-2026
Cite this page
“Think Surgical TMINI Tracking Arrays: Risk of Misalignment Due to Loose Knob.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49197-think-surgical-tmini-tracking-arrays-risk-of-misalignment-due-to. Based on FDA recall #Z-2716-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2716-2026%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Think Surgical- Category
Medical device
What to do — step by step
Check Device Codes
Identify the UDI-DI code on your TMINI Femur or Tibia Tracking Array to confirm if it matches the recalled codes.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 23 states.
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Delaware, Florida, Iowa, Kansas, Louisiana, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, Texas, Utah, Virginia, Washington.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-2716-2026 (May 8, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2716-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.