# FDA recall Z-1174-2019

> **Integra LifeSciences Corp.** · Class II · device recall initiated 2019-03-08.

## Product

Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Left, Product No. LJV192T

## Reason for recall

The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU

## Distribution

Distributors in AL, CA, CT, FL, GA, HI, IA, ID, KS, KY, MD, MI, MO, MT, NC, NE, NJ, NM, NY, OH, OK,PA, TX, VA, WA, and WI.

## Key facts

- **Recall number:** Z-1174-2019
- **Recalling firm:** Integra LifeSciences Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-08
- **Report date:** 2019-04-24
- **Termination date:** 2020-05-15

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1174-2019

## Citation

> AI Analytics. FDA recall Z-1174-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1174-2019. Source: US FDA. Licensed CC0.

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