---
title: "Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of pro... — FDA record Z-0736-2023 | Is It on Recall"
description: "Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing, all content"
url: https://isitonrecall.com/recall/fda-device-z-0736-2023-full-dose-ce-simplex-p-single-bone-cement-indicated-for-the-fixation-of-prostheses-to-living-bone-in/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Ca... — FDA record Z-0736-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Nov 7, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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**: 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.
- **Classification**: Class III
- **Recalling firm**: Howmedica Osteonics Corp.
- **Quantity**: 2085 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0736-2023

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0736-2023%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI# P/N 6191-0-001 (01)07613327128772 (17)261031(10)lot# GTIN: 07613327128772 -Instructions for Use (IFU) received with product: 0700-7-010 (IFU Radiopaque Bone Cement) All lots manufactured under Rev AB, with Exp. Date on/after September 16, 2021. |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

International distribution in the country of Turkey.

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Dec 28, 2022
- **Recall initiation date**: Nov 7, 2022
- **Center classification date**: Dec 20, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0736-2023%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Howmedica Osteonics Corp. records](https://isitonrecall.com/brand/howmedica-osteonics-corp/)