Z-0240-2023 Class II Ongoing
FDA device recall Z-0240-2023 was initiated by Howmedica Osteonics Corp. on Oct 21, 2022 and is designated Class II. 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) The recall status is ongoing. Affected quantity: 90 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 23, 2022
- Initiation Date
- Oct 21, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 90 units
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)
Distribution Pattern
US Nationwide distribution.
Code Information
UDI: (01)14260056885768(17)231130(10)145BB909GC Lot Number: 202BB943KC Exp. Date: 30/Sep/2024
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0240-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026