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CEMEX GENTA SYSTEM 60G

TECRES SPA · Model 1310/SG US · UDI-DI 28031497000484

MBB LOD Prescription

510(k) clearances

3,697

Adverse events (48 deaths)

Recalls

Facilities

Description

Cemex Genta System 60g is an antibiotic-loaded polymethylmethacrylate bone cement. Cemex Genta System 60g holds the powder (60g) and liquid (22g) components separately within a closed syringe-like device that serves as both a mixing chamber and a cement delivery system. The device is supplied sterile, for single use. Cemex Genta System 60g is indicated for the fixation of prostheses to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.

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.