# FDA recall Z-2447-2018

> **NewDeal SA** · Class II · device recall initiated 2018-05-22.

## Product

TIBIAXYS, Model Numbers: 150010S, 150020S, 150030S, 150040S,   150120S, 150110S, 150130S, 150200S, 150240S, 150242S, 150246S,   150250S, 150255S, 150260S, 150265S, 150270S, 150275S, 150280S,   150285S, 150290S, 150514S & 150516S

## Reason for recall

Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal.

## Distribution

CA, CO, CT, ID, KS, MA, MD, MN, MO, MS, NC, NY, OH, OR, PA, SD, VA, WA & WI

## Key facts

- **Recall number:** Z-2447-2018
- **Recalling firm:** NewDeal SA
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-22
- **Report date:** 2018-07-25
- **Termination date:** 2019-11-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** St Priest, France

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2447-2018

## Citation

> AI Analytics. FDA recall Z-2447-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2447-2018. Source: US FDA. Licensed CC0.

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