Bone Cement, Antibiotic
Howmedica Osteonics Corp's record for this product code
MDR events6All time
Recalls2All time
510(k) clearances1All time
Recent MDR events
6 adverse event reports on file
- TOBRA FULL DOSE ANTIBIOTIC BONE CEMENT, 10 PACKJun 13, 2025InjuryMW5171473
- DEPUY ATTUNE KNEE PROSTHESISDec 1, 2022InjuryMW5113592
- HIGH VISCOSITY BONE CEMENTSep 15, 2022InjuryMW5112078
- STRYKER HIGH VISCOSITY BONE CEMENTAug 10, 2022InjuryMW5111430
- SIMPLEX P SPEEDSET CEMENTMay 24, 2021Malfunction11869568
- DEPUY ATTUNE KNEE ARTHROPLASTY COMPONENTSMay 14, 2021InjuryMW5101372
Recalls
2 recall events for this product code
- Open, ClassifiedNov 15, 2022
Simplex HV With Gentamicin CE, 10 PACKS (P/N 6193-1-010) were distributed to customers who had ordered Simplex HV With Gentamicin in US, 10 PACKS (P/N 6195-1-010)
View FDA record ↗ - TerminatedJan 10, 2007
The expiration date on the external label is incorrect in that it does not identify the earliest expiration date of the subcomponents. The External label provides for an incorrect longer expiration date than the actual subcomponents will support.
View FDA record ↗
510(k) clearances
1 clearances for this product code