FDA-Device2022-11-23Class II

Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog Number: 6193-1-010

Howmedica Osteonics Corp.
Hazard

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)

Sold states
US Nationwide distribution.
Affected count
90 units
Manufactured in
325 Corporate Dr, N/A, Mahwah, NJ, United States
Products
Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog Number: 6193-1-010

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0240-2023

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