Recall Z-0951-2023— Depuy Ireland UC

Name: FDA recall Z-0951-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-19

Class II · Ongoing

Class II FDA medical device recall by Depuy Ireland UC, initiated 2022-12-19. It names one FDA 510(k) clearance: K943727. 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). 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..

Recalling firm: Depuy Ireland UC
Classification: Class II
Status: Ongoing
Initiated: 2022-12-19
Firm location: Co. Cork Munster, Ireland

510(k) clearances named in this recall

1 on FDA's record

K943727 — BIOSTOP G BONE CEMENT RESTRICTORLandos, Inc.·cleared 1995-05-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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)

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.