# FDA recall Z-0618-2024

> **Acumed LLC** · Class II · device recall initiated 2023-11-27.

## Product

RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320    The RBL2320, Low Profile Primary Guide is an instrument used with a power system to  compress the RibLoc plates onto the bone, determine the length of the screw to install, locate the position of the holes to drill, and provide proper orientation for the installation of the screws.

## Reason for recall

Due to potential breakage during use.

## Distribution

Worldwide - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, NJ, OH, OR, SC, TX, UT, VA, WA, and WI. The country of Australia.

## Key facts

- **Recall number:** Z-0618-2024
- **Recalling firm:** Acumed LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-27
- **Report date:** 2024-01-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hillsboro, OR, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0618-2024

## Citation

> AI Analytics. FDA recall Z-0618-2024. Retrieved 2026-06-15 from https://api.ai-analytics.org/recall/Z-0618-2024. Source: US FDA. Licensed CC0.

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