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Depuy Ireland UC Recalls

1 recall on record · January 18, 2023 to January 18, 2023 · Medical Devices

January 18, 2023Medical DevicesFDA

Depuy Ireland UC recalls BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR Catalog Numbers: 546308000 (Size 8); 546310000 (Size 10); 546312000 (Size 1

Hazard: All lots of BIOSTOP G Bioresorbable Cement Restrictor are being removed as a precautionary measure because tested endotoxin levels were higher than recommended by the current FDA regulatory guidance. In general, endotoxins have a potential to initiate inflammatory responses, ranging from a mild fever to potentially impact or damage to vital organs.

Depuy Ireland UC Recalls | RecallWatchUSA