Howmedica Osteonics Corp. Recall 91147
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
Howmedica Osteonics Corp. Recall 91147 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0736-2023 |
| Event ID | 91147 |
| Event 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 Type | Devices |
| Distribution | International distribution in the country of Turkey. |
| Quantity | 2085 units |
| Recall 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. |
| Device Classification | 20221228 |
| Device Code Info | 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. |
| Center Classification Date | 20221220 |
| Recall Initiation Date | 20221107 |
| Recalling Firm | Howmedica Osteonics Corp. |
| Initial Notification | |
| Similar To |