Howmedica Simplex HV Bone Cement with Gentamicin Recall: Risk of Infection
Howmedica recalls 10-pack bone cement with Gentamicin (P/N 6193-1-010) due to potential infection risk. Affected customers should contact Howmedica for details.
Lower-risk 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)
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What happened, in plain English
Howmedica is recalling 10-packs of Simplex HV bone cement with Gentamicin (P/N 6193-1-010) because it may cause infections. This recall affects patients who received this specific product for bone repair procedures. Read more at govinfonow.com/recall/59819-howmedica-simplex-hv-bone-cement-with-gentamicin-recall-risk-of.
Source Summary by GovInfoNow · govinfonow.com/recall/59819-howmedica-simplex-hv-bone-cement-with-gentamicin-recall-risk-of · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0240-2023
Cite this page
“Howmedica Simplex HV Bone Cement with Gentamicin Recall: Risk of Infection.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/59819-howmedica-simplex-hv-bone-cement-with-gentamicin-recall-risk-of. Based on FDA recall #Z-0240-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0240-2023%22&limit=1).
Why it’s dangerous
The bone cement contains Gentamicin, an antibiotic that may not be effective in all cases, potentially leading to infections. This risk is specific to the 10-pack version with the catalog number 6193-1-010.
Who’s affected
Patients who received the Simplex HV bone cement with Gentamicin (P/N 6193-1-010) for bone repair procedures in the U.S. are most at risk. This product was distributed to customers who ordered the 10-pack version (P/N 6195-1-010).
How to tell if you have this one
Check for the catalog number 6193-1-010 on the product label. The product was distributed to customers who ordered the 10-pack version (P/N 6195-1-010) in the U.S. between the dates of the product's distribution.
- Brand
Howmedica- Product
Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog Number: 6193-1-010- Category
Medical device
What to do — step by step
Check Product Label
Look for the catalog number 6193-1-010 on the bone cement packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 33 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product safe to use?
The recall indicates a potential infection risk, so it is not recommended for use without consulting Howmedica.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0240-2023 (October 21, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0240-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.