Use caution Medical device recall · FDA · Published March 30, 2018

Think Surgical Cutter Recall: Cutter Head May Detach During Use

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2605-2018Medical device Think Surgical ›

Use caution until it’s fixed

There is a potential for the cutter head to detach from the cutter shaft.

Take action

Contact the company

Recalling firmThink Surgical, Inc.47201 Lakeview Blvd · Fremont, CA 94538-6530

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/71563-think-surgical-cutter-recall-cutter-head-may-detach-during-use.

Source Summary by GovInfoNow · govinfonow.com/recall/71563-think-surgical-cutter-recall-cutter-head-may-detach-during-use · Updated August 21, 2026 · FDA enforcement record: FDA #Z-2605-2018

Cite this page

“Think Surgical Cutter Recall: Cutter Head May Detach During Use.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71563-think-surgical-cutter-recall-cutter-head-may-detach-during-use. Based on FDA recall #Z-2605-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2605-2018%22&limit=1).

The FDA announced on March 30, 2018, that Think Surgical, Inc. voluntarily recalled its Think Surgical Cutter, Flat, 6.2mm x 144mm due to a potential for the cutter head to detach from the shaft. The agency classified the recall as Class II.

How to tell if you have it

Brand: Think Surgical
Product: Think Surgical Cutter, Flat, 6.2mm x 144mm
Part Number: 106428
Lot Numbers: 9158, 9519, 9209, 9230, 9269, 9288, 9834, 9869, 10201, 100496, 1626303, 9287, 9563, 9642, 9855, 9890, 10313
Quantity: 951 units

The hazard

According to the FDA, there is a potential for the cutter head to detach from the cutter shaft. The device is used to prepare bone for Total Knee Arthroplasty (TKA) and is intended for use only with the TCAT Computer-Assisted Tool.

Context

GovInfoNow's records show Think Surgical, Inc. has two other recalls on record since February 12, 2024. Other recent recalls of similar products include Olympus PK Cutting Forceps Recall (February 25, 2026), D.O.R.C. TDC VELOCE 27G Cutter Recall (April 30, 2026), and Merit Medical Custom Procedure Kit Recall (December 4, 2025).

How to tell if you have this one

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.

Brand
Think Surgical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for part number 106428 and lot numbers listed above to confirm if your cutter is affected.

Where it went and when

Where it was distributed

Distributed in 4 states, and outside the U.S.

FDA distribution: “The devices were distributed to the following US states: NJ, NY, OH, and TX. The devices were also distributed to Korea.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: New Jersey, New York, Ohio, Texas.

Recall timeline

FDA terminated this recall 22 months after the firm started it.

Mar 30, 2018Firm started the recall
Aug 3, 2018FDA classified it Class II
Aug 15, 2018Published in FDA’s Enforcement Report
Jan 24, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is this product safe to use?

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.

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Link to this recall

<a href="https://govinfonow.com/recall/71563-think-surgical-cutter-recall-cutter-head-may-detach-during-use">Think Surgical Cutter Recall: Cutter Head May Detach During Use (GovInfoNow)</a>

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-2605-2018 (March 30, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2605-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 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.