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Bone Cement

FDA product code LOD · Class 2 · Orthopedic

188
Registered devices
13,130
Adverse events
34
Recalls
72
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2025-12-09Heraeus 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 imp
2025-12-09Heraeus 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 imp
2025-12-09Heraeus 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 imp
2025-12-09Heraeus 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 imp
2022-11-07Howmedica 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 conten
2022-11-07Howmedica 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 conten
2021-03-22BIOPSYBELL S.R.L.Products labeled as sterile were distributed, but may not have been sterilized.
2021-03-22BIOPSYBELL S.R.L.Products labeled as sterile were distributed, but may not have been sterilized.
2021-03-22BIOPSYBELL S.R.L.Products labeled as sterile were distributed, but may not have been sterilized.
2021-03-22BIOPSYBELL S.R.L.Products labeled as sterile were distributed, but may not have been sterilized.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.