Think Surgical recalls flat cutters (part 106428) for potential cutter head detachment. Affected units sold with TCAT tool; stop using if you own this specific model.
There is a potential for the cutter head to detach from the cutter shaft.
Think Surgical is recalling flat cutters (part number 106428) that may detach from the cutter shaft during use. This could cause injury during total knee replacement surgery. Affected units have specific lot numbers listed in the recall notice.
The cutter head may detach from the cutter shaft during use, which could lead to injury if the detached part causes a cut or other harm during surgery. This is a specific risk for the surgical procedure being performed.
Surgical professionals using the Think Surgical Cutter with TCAT Computer-Assisted Tool for total knee replacements. Those with the listed lot numbers are most at risk.
Check the product label for part number 106428 and lot numbers: 9158, 9519, 9209, 9230, 9269, 9288, 9834, 9869, 10201, 100496, 1626303, 9287, 9563, 9642, 9855, 9890, 10313. The cutter is designed for use only with the TCAT Computer-Assisted Tool.
Look for part number 106428 and lot numbers listed above to confirm if your cutter is affected.
The recall states there is a potential for the cutter head to detach, so it is not safe to use without checking the recall status.
The recall does not specify a remedy, so you should check the official recall notice for further instructions.
Check the product label for part number 106428 and lot numbers: 9158, 9519, 9209, 9230, 9269, 9288, 9834, 9869, 10201, 100496, 1626303, 9287, 9563, 9642, 9855, 9890, 10313.
We’ve drafted a message you can send Think Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-2605-2018 — Think Surgical Think Surgical Hello, I own a Think Surgical that is covered by recall Z-2605-2018 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.
