Howmedica Osteonics Corp.: Medical Device Recall in 2022 - (Recall #: Z-0240-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 21, 2022

Date Posted: November 23, 2022

Recall Number: Z-0240-2023

Event ID: 91044

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)

Status: Ongoing

Product Quantity: 90 units

Code Information:

UDI: (01)14260056885768(17)231130(10)145BB909GC Lot Number: 202BB943KC Exp. Date: 30/Sep/2024

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated