Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number: 6191-0-001
Reported: December 28, 2022 Initiated: November 7, 2022 #Z-0736-2023
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
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.
Details
- Recalling Firm
- Howmedica Osteonics Corp.
- Units Affected
- 2085 units
- Distribution
- International distribution in the country of Turkey.
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number: 6191-0-001. Recalled by Howmedica Osteonics Corp.. Units affected: 2085 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 28, 2022. Severity: Low. Recall number: Z-0736-2023.
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