# FDA recall Z-1318-2024

> **Think Surgical, Inc.** · Class II · device recall initiated 2024-02-12.

## Product

Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic System

## Reason for recall

There is a galling effect (cold-weld) caused by friction between the array fixation pins and the TMINI array guide holes due to insufficient clearance between the outer diameter of the fixation pins and the inner diameter of the TMINI array guide holes. As a result, the array guide has the possibility of binding to the array fixation pins during drilling.

## Distribution

US Nationwide distribution in the states of AL, OH, NV, TX, UT, CA, MO.

## Key facts

- **Recall number:** Z-1318-2024
- **Recalling firm:** Think Surgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-02-12
- **Report date:** 2024-03-27

- **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-1318-2024

## Citation

> AI Analytics. FDA recall Z-1318-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1318-2024. Source: US FDA. Licensed CC0.

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