Reported Aug 15, 2018 · Terminated

Think Surgical Cutter, Flat, ¿6.2mm x 144mm. For use only with the TCAT Computer-Assisted Tool. Part Number 106428 The…

Think Surgical, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Think Surgical, Inc. · 47201 Lakeview Blvd · Fremont, CA · 94538-6530

Is this the product you have?

  • 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.
Lot codes and dates
    • Lot Numbers 9158
    • 9519
    • 9209
    • 9230
    • 9269
    • 9288
    • 9834
    • 9869
    • 10201
    • 100496
    • 1626303
    • 9287
    • 9563
    • 9642
    • 9855
    • 9890
    • 10313
Amount recalled
951

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 24, 2020 · Data as of Sep 19, 4:15 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.