Howmedica Osteonics Corp.: Medical Device Recall in 2022 - (Recall #: Z-0736-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: November 7, 2022

Date Posted: December 28, 2022

Recall Number: Z-0736-2023

Event ID: 91147

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.

Status: Ongoing

Product Quantity: 2085 units

Code Information:

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.

Distribution Pattern:

International distribution in the country of Turkey.

Voluntary or Mandated:

Voluntary: Firm initiated