Depuy Ireland UC Loughbeg, Ringaskiddy Co. Cork Munster Ireland 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) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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)
Brand
Depuy Ireland UC Loughbeg, Ringaskiddy Co. Cork Munster Ireland
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Catalog Number Part Description UDI/DI * 546308000 BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 8 10603295174547 546310000 BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 10 10603295174554 546312000 BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 12 10603295174561 546314000 BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 14 10603295174578 546316000 BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 16 10603295174585 546318000 BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 18 10603295174592 546320000 BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 20 10603295174608 * UDI-DI on GS1 0603295a0035792 Expiry dates December 2022 thru May 2025 ALL LOTS
Depuy Ireland UC Loughbeg, Ringaskiddy Co. Cork Munster Ireland is recalling BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR Catalog Numbers: 546308000 (Size 8); 546310000 (Size 10); due to All lots of BIOSTOP G Bioresorbable Cement Restrictor are being removed as a precautionary measure because tested endotoxin levels were higher than re. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 synthes5716@sedgwick.com or call 888-597-5387 to coordinate the return/credits of the subject products.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026