PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: November 23, 2022 Initiated: October 21, 2022 #Z-0240-2023

Product Description

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

Reason for Recall

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)

Details

Recalling Firm
Howmedica Osteonics Corp.
Units Affected
90 units
Distribution
US Nationwide distribution.
Location
Mahwah, NJ

Frequently Asked Questions

What product was recalled?
Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog Number: 6193-1-010. Recalled by Howmedica Osteonics Corp.. Units affected: 90 units.
Why was this product recalled?
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)
Which agency issued this recall?
This recall was issued by the FDA Devices on November 23, 2022. Severity: Moderate. Recall number: Z-0240-2023.