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MectaCem-X LV with Gentamicin
TECRES SPA · Model 65.01.113US · UDI-DI 08031497002149
10
510(k) clearances
13,130
Adverse events (469 deaths)
34
Recalls
81
Facilities
Description
MectaCem-X LV with Gentamicin is a low viscosity antibiotic-loaded polymethylmethacrylate bone cements. It is composed by two components (40g powder and 14,7g liquid) which are designed for mixing together at the point of use to form the cement. The device is supplied sterile, for single use. MectaCem-X LV with Gentamicin 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 |
|---|---|---|
| 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. |
| 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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Get your free API keyRead the docsData 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.