# FDA recall Z-2605-2018

> **Think Surgical, Inc.** · Class II · device recall initiated 2018-03-30.

## 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

- **Recall number:** Z-2605-2018
- **Recalling firm:** Think Surgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-2605-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2605-2018. Source: US FDA. Licensed CC0.

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