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)
FDA Recall Z-0951-2023 · Posted 2023-01-12
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Recalling FirmDepuy Ireland UC
Recall StatusOpen, Classified
Product CodeLZN
Date Initiated2022-12-19
Product Quantity2199 US; 43515 OUS
Reason for Recall
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.
Firm Action
On December 19, 2022, the firm notified affected consignees through "Urgent Medical Device Recall" letters. Customers were instructed to immediately identify and quarantine affected product in inventory. Recalled products should not be used. Customers should then contact Sedgwick at [email protected] or call 888-597-5387 to coordinate the return/credits of the subject products.
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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