Device 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
Z-0736-2023
Product summary
- Event
- Event 91147
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 2085 units
- Official record key
device-enforcement:Z-0736-2023
Official wording
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.
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.
Derived failure modes
-
Unknown
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.