Recall Z-0951-2023 ยท LZN Cement Obturator
Depuy Ireland UC
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)
| Date | Jan 12, 2023 (initiated Dec 19, 2022) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| 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 synthes5716@sedgwick.com or call 888-597-5387 to coordinate the return/credits of the subject products. |
| Quantity | 2199 US; 43515 OUS |
| Distribution | 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, Portug |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K943727 | BIOSTOP G BONE CEMENT RESTRICTOR Landos, Inc., May 11, 1995 |