CLASS II Device recall · Reported 15 Aug 2018 · FDA Enforcement Report

Cutter, Flat, ¿ For use only with the TCAT Computer-Assisted Tool recalled

Think Surgical is recalling Cutter, Flat, ¿ For use only with the TCAT Computer-Assisted Tool, distributed in New Jersey, New York, Ohio, Texas. The recall was initiated on 30 Mar 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers 9158, 9519, 9209, 9230, 9269, 9288, 9834, 9869, 10201, 100496, 1626303, 9287, 9563, 9642, 9855, 9890, 10313

Quantity recalled951

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2605-2018
FDA event ID: 80091
Recalling firm: Think Surgical, Fremont, CA
Classification: Class II
Status: Terminated
Recall initiated: 30 Mar 2018
FDA classified: 3 Aug 2018
Reported: 15 Aug 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

30 Mar 2018	Recall initiated by company
3 Aug 2018	Classified by FDA	+126 days
15 Aug 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

Think Surgical Cutter, Flat, ¿6.2mm x 144mm. For use only with the TCAT Computer-Assisted Tool. Part Number 106428 The cutter is used to prepare the bone for the (TKA) Total Knee Arthroplasty.

Where it was distributed

The devices were distributed to the following US states: NJ, NY, OH, and TX. The devices were also distributed to Korea.

New Jersey New York Ohio Texas

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot Numbers 9158, 9519, 9209, 9230, 9269, 9288, 9834, 9869, 10201, 100496, 1626303, 9287, 9563, 9642, 9855, 9890, 10313

Where was it sold?

The devices were distributed to the following US states: NJ, NY, OH, and TX. The devices were also distributed to Korea.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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