FDA recall Z-2605-2018

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.

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2018-03-30

Report date

2018-08-15

Termination date

2020-01-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fremont, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2605-2018