# FDA recall Z-1986-2019

> **Clariance Inc** · Class III · device recall initiated 2019-07-01.

## Product

Erisma- LP posterior fixation system with the below specifically affected products:      1. Erisma-LP polyaxial screws - 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 105 mm (all lengths);      2. Erisma-LP Screwdriver;      3. Erisma-LP T20 Wrench;      4. Erisma-LPT20 Snap Fit Tightening Wrench

## Reason for recall

Potential for the polyaxial screw to become disassembled during implant.

## Distribution

Nationwide distribution to CA, IL, IN, NY, OH, TX.

## Key facts

- **Recall number:** Z-1986-2019
- **Recalling firm:** Clariance Inc
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-01
- **Report date:** 2019-07-24
- **Termination date:** 2020-07-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Chicago, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1986-2019

## Citation

> AI Analytics. FDA recall Z-1986-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1986-2019. Source: US FDA. Licensed CC0.

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