FDAOctober 31, 2022device
Unity Total Knee System. Used for knee prosthesis in total knee replacement
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.
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, 036mm EX LONG +8mm, REF 104.36152022-11-08
- FDACorin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.32152022-11-08
- 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
- FDACorin BIOLOX Delta Mod Head, diameter 28mm Medium 0mm, 12/14 Taper, REF 104.2805, Sterile, a component of the Trinity Acetabular System.2021-07-28
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