# FDA recall Z-1717-2019

> **OMNIlife science Inc.** · Class II · device recall initiated 2019-04-12.

## Product

OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iBlock Cutting Guide is a stainless-steel surgical instrument used during total knee arthroplasty. Specifically, the iBlock Cutting Guide is used in conjunction with the iBlock Saw Guide with the OMNIBot  robotic Motor Unit, and for preparation of the bone for implant implantation. The instrument has been designed to facilitate bone preparation and implantation of the OMNI Apex Knee System.

## Reason for recall

The OMNIBotics iBlock Cutting Guide does not lock onto the iBlock Saw Guide as  intended and may loosen during use.

## Distribution

US Nationwide distribution in the states of OK, SC, and WI.

## Key facts

- **Recall number:** Z-1717-2019
- **Recalling firm:** OMNIlife science Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-04-12
- **Report date:** 2019-06-12
- **Termination date:** 2020-05-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Raynham, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1717-2019

## Citation

> AI Analytics. FDA recall Z-1717-2019. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1717-2019. Source: US FDA. Licensed CC0.

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