Home / Recalls / Think Surgical, Inc. / Z-2605-2018

Z-2605-2018 Class II Terminated

Recalled by Think Surgical, Inc. — Fremont, CA

Recall Details

Product Type: Devices
Report Date: August 15, 2018
Initiation Date: March 30, 2018
Termination Date: January 24, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 951

Product Description

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.

Reason for Recall

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

Distribution Pattern

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

Code Information

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