Product complaint#: (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: device history reviewed on 20 dec 2019 under (b)(4).2 unrelated non-conformances on this lot number.Final micro and sterility tests passed.(b)(4) units released.There were no anomalies with this lot.Dmf#: 13704.Trade name ¿ gentamicin sulphate.Active ingredient(s) ¿ gentamicin sulphate.Dosage form - powder.Strength ¿ 1.0g active in our cements corrected: d2b.
|