FDA-Device2018-08-15Class II
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.
Think Surgical, Inc.
Hazard
There is a potential for the cutter head to detach from the cutter shaft.
Sold states
The devices were distributed to the following US states: NJ, NY, OH, and TX. The devices were also distributed to Korea.
Affected count
951
Manufactured in
47201 Lakeview Blvd, N/A, Fremont, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2605-2018Don't want to check this manually?
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