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Depuy Ireland UC recalls BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR Catalog Numbers: 546308000 (Size 8); 546310000 (Size 10); 546312000 (Size 1
Recalled January 18, 2023 · FDA recall Z-0951-2023 · Depuy Ireland UC
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. · FDA Class II
Units
2199 US; 43515 OUS
Sold at
Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Hungary, Ireland, Israel, Italy, Latvia, Lebanon, Luxemburg, Mexico, Netherlands, New Zealand, Norway, Portugal, Reunion, Romania, Russia, Slovakia, South Africa, Spain, Sweden, Switzerland, and Uruguay.
Description
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.
Product
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)
Manufacturer(s)
Depuy Ireland UC
Made in
Ireland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →