OSTEOPAL®
Heraeus Medical GmbH · Model V · UDI-DI 04260102139411
Description
OSTEOPAL® V is a standard-setting, low-viscosity, radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement. 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. The low viscosity increases with progressing polymerization. A paste forms that is inserted into the vertebral body using an application system and sets within a few minutes. OSTEOPAL® V is intended for single use and is supplied sterile.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-20 | Heraeus Medical GmbH (Dental Division) | Potential for monomer liquid leakage. |
| 2026-08-20 | Heraeus Medical GmbH (Dental Division) | Potential for monomer liquid leakage. |
| 2025-12-09 | Heraeus Medical GmbH (Dental Division) | increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule b |
| 2025-12-09 | Heraeus Medical GmbH (Dental Division) | increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule b |
| 2025-12-09 | Heraeus Medical GmbH (Dental Division) | increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule b |
| 2025-12-09 | Heraeus Medical GmbH (Dental Division) | increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule b |
| 2022-11-07 | Howmedica Osteonics Corp. | Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing, all content within the IFUs is |
| 2022-11-07 | Howmedica Osteonics Corp. | Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing, all content within the IFUs is |
| 2021-03-22 | BIOPSYBELL S.R.L. | Products labeled as sterile were distributed, but may not have been sterilized. |
| 2021-03-22 | BIOPSYBELL S.R.L. | Products labeled as sterile were distributed, but may not have been sterilized. |
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