The FDA announced on September 21, 2018, that DePuy Orthopaedics, Inc. voluntarily recalled CORAIL AMT STANDARD OFFSET NECK SEGMENT (STD) neck trials due to potential debris behind O-rings. The recall affects 12,639 units distributed worldwide and in the United States.
How to tell if you have it
- Brand: DePuy
- Product: CORAIL AMT STANDARD OFFSET NECK SEGMENT (STD), Pro. Code L20431
- Lots: 1212901, 1218481, 1226220, 1230761, 1230762, 1700575, 1781381, 1812714, 1817780, 1860264, 1865892, 1874689, 1874692, 1874695, 1885306, 1899212, 1899213, 1910187, 1979239, 2002010, 2024019, 2043428, 2078239, 2102693, 2129111, 2153317, 2153318, 2153319, 2153320, 2163174, 2249115, 2249116, 2252364, 2274452, 2275487, 2284306, 2284307, 2309644, 2309645, 2309646, 2336389, 2336390, 2362086, 2362087, 2380243, 2384473, 2384474, 2386339, 2401664, 2401665, 2416615, 2416617, 2416618, 2465273, 2465274, 2465275, 2465287, 2490513, 2490514, 2513465, 2513466, 2526363, 2526364, 2539884, 2539885, 2565583, 2572825, 2572826, 2602513, 2602514, 2605764, 2605765, 2643408, 2643409, 2648066, 2648067, 2673433, 2673434, 2691497, 2691501, 2739089, 2739090, 2749282, 2749283, 2774407, 2774408, 2774409, 2774410, 2795717, 2795718, 2795719, 2811227, 2811228, 2811233, 2811234, 2836707, 2836708, 2836709, 5001519, 5001520, 5001521, 5001522, 5005846, 5005847, 5008238, 5008239, 5009208, 5016192, 5016193, 5016194, 5016195, 5016196, 5019838, 5019841, 1812714A
The hazard
According to the FDA, there is the potential for debris or material to be found behind the O-rings in the neck trials. The affected products are surgical instruments used in CORAIL total and partial hip arthroplasty.
Context
GovInfoNow's records show DePuy Orthopaedics, Inc. has 23 other recalls on record since July 12, 2017. Other recent recalls of similar products include ATTUNE Knee Component Due to Incorrect Labeling (March 12, 2024), Attune Revision Limb Preservation Tibial Insert XSM 26MM Recall (February 15, 2023), and ATTUNE Sizing Guide Recall (June 29, 2022). Other recent recalls of similar products include Depuy ATTUNE Revision Hinge Femoral LT SZ 5 CEM, Depuy ATTUNE Revision Hinge Femoral LT SZ 8 CEM, and Depuy ATTUNE Revision Hinge Femoral RT SZ 3 CEM (April 3, 2026).