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.
Think Surgical is recalling the TMINI Array Guide (part REF: 109101) because it can bind during drilling due to friction between pins and holes. This could cause the guide to stick, potentially leading to inaccurate surgery or damage to the surgical site.
The array guide can bind during drilling because the pins and holes have insufficient clearance. This friction causes a cold-weld effect, which might make the guide stick to the pins and interfere with precise surgical movements.
Surgical teams using the TMINI Knee Instrument Set with the TMINI Miniature Robotic System. The risk is highest for those operating with the specific lot numbers listed in the recall.
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.
Look for the part number REF: 109101 and the UDI-DI code M9461091010 on the TMINI Array Guide.
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.
Check for the part number REF: 109101 and lot numbers: 2316701, 2232601, 23030, 2228501, 2327802, or 22152. The UDI-DI code is M9461091010.
The recall does not specify a remedy, so contact Think Surgical directly for guidance.
We’ve drafted a message you can send Think Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1318-2024 — Think Surgical Think Surgical Hello, I own a Think Surgical that is covered by recall Z-1318-2024 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.
