COPAL® G+V
Heraeus Medical GmbH · Model 1x40 · UDI-DI 04260102139855
Description
COPAL® G+V is a standard-setting, high-viscosity, radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement and designed for fixation of COPAL® exchange G hip spacer to the host bone. It contains the aminoglycoside antibiotic gentamicin and the glycopeptide antibiotic vancomycin to protect the cured bone cement and surrounding tissue from colonization by bacteria that are sensitive to gentamicin and/or vancomycin. It contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex(E141). The bone cement consists of two components and is prepared immediately before use by mixing the polymer powder with the monomer liquid. COPAL® G+V is intended for single-use and is supplied sterile.
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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docs