FDAJuly 28, 2021device
Corin Trinity Dual Mobility, Size 4, Dual Mobility CoCr Liner, REF 321.04.540, Sterile, and Corin Dual Mobility, Size 4 42 insert/28 head, REF 325.04.042, Sterile; both are components of the Trinity Dual Mobility System.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
What to do
FDA enforcement status: Terminated
Brands named
corin
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAApex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-552432025-05-23
- FDAUnity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revision total knee arthroplasty2023-10-13
- FDAUnity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty2023-10-13
- FDACorin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.32152022-11-08
- FDACorin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.36152022-11-08
- FDAUnity Total Knee System. Used for knee prosthesis in total knee replacement2022-10-31
- FDACorin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 579.01032022-07-22
- FDATaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip implant component.2022-07-12
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