CLASS II ONGOING Device recall · Reported 23 Nov 2022 · FDA Enforcement Report

Simplex HV With Gentamicin CE-Bone cement with Gentomycin recalled

Howmedica Osteonics is recalling Simplex HV With Gentamicin CE-Bone cement with Gentomycin, distributed nationwide in the US. The recall was initiated on 21 Oct 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: (01)14260056885768(17)231130(10)145BB909GC Lot Number: 202BB943KC Exp. Date: 30/Sep/2024

Quantity recalled90 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0240-2023
FDA event ID: 91044
Recalling firm: Howmedica Osteonics, Mahwah, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 21 Oct 2022
FDA classified: 15 Nov 2022
Reported: 23 Nov 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

21 Oct 2022	Recall initiated by company
15 Nov 2022	Classified by FDA	+25 days
23 Nov 2022	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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)

Product as listed by the FDA

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

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Is Simplex HV With Gentamicin CE-Bone cement with Gentomycin recalled?

Yes. Howmedica Osteonics recalled Simplex HV With Gentamicin CE-Bone cement with Gentomycin on 21 Oct 2022. The recall is Class II and its status is Ongoing. Recall number Z-0240-2023.

Why was it 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 lots are affected?

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

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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