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

Recalled August 15, 2018 · FDA recall Z-2605-2018 · Think Surgical

Hazard

There is a potential for the cutter head to detach from the cutter shaft. · FDA Class II

Units

951

Sold at

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

Description

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

Product

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.

Manufacturer(s)

Think Surgical, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →