Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:6197-1-001
Reported: December 28, 2022 Initiated: November 7, 2022 #Z-0737-2023
Product Description
Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:6197-1-001
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
- 20 units
- Distribution
- International distribution in the country of Turkey.
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:6197-1-001. Recalled by Howmedica Osteonics Corp.. Units affected: 20 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-0737-2023.
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