Lower riskMedical device recall · FDA · Published February 12, 2024
Think Surgical TMINI Array Guide Recall: Binding Risk During Drilling
Think Surgical recalls TMINI Array Guide TMINI Knee Instrument Set part REF: 109101 due to potential binding during drilling from pin-hole friction. Affected units have specific lot numbers and UDI-DI codes.
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.
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Contact the company
📍Recalling firmThink Surgical, Inc.47201 Lakeview Blvd · Fremont, CA 94538-6530
“Think Surgical TMINI Array Guide Recall: Binding Risk During Drilling.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/56170-think-surgical-tmini-array-guide-recall-binding-risk-during-drilling. Based on FDA recall #Z-1318-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1318-2024%22&limit=1).
The FDA announced on Feb. 12, 2024, that Think Surgical, Inc. is recalling the Assembly, Array Guide TMINI (REF: 109101) due to a galling effect that may cause the guide to bind during drilling. The agency issued recall number Z-1318-2024 for the Class II device.
Lot Numbers: 2316701, 2232601, 23030, 2228501, 2327802, 22152
UDI-DI: M9461091010
The hazard
GovInfoNow's records show the hazard involves a galling effect caused by friction between array fixation pins and TMINI array guide holes due to insufficient clearance. This may result in the array guide binding to the pins during drilling.
Context
Think Surgical has two other recalls on record since March 30, 2018: a May 8, 2026 recall for TMINI Tracking Arrays regarding misalignment risk and a March 30, 2018 recall for a Cutter with potential head detachment. Other recent recalls of similar products include the Zimmer Off-Axis Alliance Glenoid Reamer Guide (May 20, 2026), the Intuitive Surgical Da Vinci Surgical System (April 22, 2026), and the restor3d Kinos Axiom Ankle Implant (July 27, 2026).
How to tell if you have this one
Check for the part number REF: 109101 on the TMINI Array Guide. Affected units have specific lot numbers: 2316701, 2232601, 23030, 2228501, 2327802, 22152. The UDI-DI code is M9461091010.
Brand
Think Surgical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the part number REF: 109101 and the UDI-DI code M9461091010 on the TMINI Array Guide.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 7 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of AL, OH, NV, TX, UT, CA, MO.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, Missouri, Nevada, Ohio, Texas, Utah.
Recall timeline
FDA published this recall 44 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The recall is for potential binding during drilling, which could affect surgical precision but is not described as causing serious injury. The risk is low.
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-1318-2024 (February 12, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1318-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.