FDA Device Intelligence
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Cement Obturator

FDA product code LZN · Class 2 · General, Plastic Surgery

116
Registered devices
212
Adverse events
8
Recalls
37
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2023-08-07Stryker CorporationPotential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potenti
2023-08-07Stryker CorporationPotential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potenti
2023-08-07Stryker CorporationPotential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potenti
2023-08-07Stryker CorporationPotential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potenti
2023-08-07Stryker CorporationPotential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potenti
2023-08-07Stryker CorporationPotential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potenti
2023-08-07Stryker CorporationPotential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potenti
2022-12-19Depuy Ireland UCAll lots of BIOSTOP G Bioresorbable Cement Restrictor are being removed as a precautionary measure because tested endotoxin levels were higher than recommended

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