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Mendec Spine HV System
TECRES SPA · Model 13C2040 · UDI-DI 28031497001382
1
510(k) clearances
13,179
Adverse events (469 deaths)
34
Recalls
81
Facilities
Description
Mendec Spine HV System is indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty or kyphoplasty procedure. Mendec Spine HV System is a closed sysyem which containes the powder and liquid components separately. The device is disposable and sterile.
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.