# FDA recall Z-0736-2023

> **Howmedica Osteonics Corp.** · Class III · device recall initiated 2022-11-07.

## Product

Full Dose CE Simplex P Single Bone Cement	- Indicated for the fixation of prostheses to living bone in orthopaedic  Catalog Number: 6191-0-001

## Reason for recall

Instructions for Use (IFU) included in the packaging  is missing a translation in the Turkish language.  Although the Turkish translation is missing, all content within the IFUs is accurate.

## Distribution

International distribution in the country of Turkey.

## Key facts

- **Recall number:** Z-0736-2023
- **Recalling firm:** Howmedica Osteonics Corp.
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-11-07
- **Report date:** 2022-12-28

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0736-2023

## Citation

> AI Analytics. FDA recall Z-0736-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0736-2023. Source: US FDA. Licensed CC0.

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