FDADecember 19, 2022device

BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR Catalog Numbers: 546308000 (Size 8); 546310000 (Size 10); 546312000 (Size 12); 546314000 (Size 14); 546316000 (Size 16); 546318000 (Size 18); 546320000 (Size 20)

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

depuy ireland ucdepuydepuy ireland

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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