# FDA recall Z-0243-2020

> **Alto Development Corp** · Class II · device recall initiated 2019-09-10.

## Product

A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S.  For fracture fixation or reconstruction of the sternum.

## Reason for recall

Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensioner inoperable.

## Distribution

Distributed to AL, CA, FL, GA, IL, LA, MO, OK, MS, NM, OK, SC, TX, UT, VT, WA, and WI.

## Key facts

- **Recall number:** Z-0243-2020
- **Recalling firm:** Alto Development Corp
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-09-10
- **Report date:** 2019-11-06
- **Termination date:** 2020-05-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wall Township, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0243-2020

## Citation

> AI Analytics. FDA recall Z-0243-2020. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-0243-2020. Source: US FDA. Licensed CC0.

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