Reported Jan 18, 2023 · Ongoing
BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR Catalog Numbers: 546308000 (Size 8); 546310000 (Size 10); 546312000 (Size…
Depuy Ireland UC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Depuy Ireland UC · Loughbeg, Ringaskiddy · Co. Cork Munster · N/A
Is this the product you have?
- 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)
- Lot codes and dates
- 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
- Amount recalled
- 2199 US; 43515 OUS
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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