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BonOs HV Genta

OSARTIS GmbH · Model 1x40 · UDI-DI 04260056882623

MBB LOD Prescription

510(k) clearances

3,709

Adverse events (49 deaths)

Recalls

Facilities

Description

BonOs® HV Genta is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone. BonOs® HV Genta cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium. BonOs® HV Genta does not emit a signal and does not pose a safety risk in a magnetic resonance environment.

Recalls

Date	Firm	Reason
2022-10-21	Howmedica Osteonics Corp.	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)
2015-02-11	DePuy Orthopaedics, Inc.	One lot of SMARTSET GHV Gentamicin Bone Cement is partially agglomerated . This may result in surgical delays while a replacement package of cement is retrieved and mixed.
2013-11-04	Zimmer, Inc.	The patient label associated with the product may be incorrect in that the lot number on the patient label may be different than the lot number on the outer carton label.
2013-09-16	DePuy Orthopaedics, Inc.	The SmartSet GMV Endurance Gentamicin Bone Cement, product ref: number 3105-040 is intended for use in indications that have not been cleared by the US FDA. The intended use stated
2006-11-07	Stryker Howmedica Osteonics Corp.	The expiration date on the external label is incorrect in that it does not identify the earliest expiration date of the subcomponents. The External label provides for an incorrect

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.