FDA-Device2022-12-28Class III
Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:6197-1-001
Howmedica Osteonics Corp.
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.
Sold states
International distribution in the country of Turkey.
Affected count
20 units
Manufactured in
325 Corporate Dr, Mahwah, NJ, United States
Products
Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:6197-1-001
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0737-2023Don't want to check this manually?
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