Howmedica Osteonics Corp. recalls Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Cata

Recalled December 28, 2022 · FDA recall Z-0736-2023 · Howmedica Osteonics

Hazard

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. · FDA Class III

Units

2085 units

Sold at

International distribution in the country of Turkey.

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 within the IFUs is accurate.

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

Manufacturer(s)

Howmedica Osteonics Corp.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →