FDAOctober 13, 2023device
Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa.
What to do
FDA enforcement status: Ongoing
Brands named
corin
UPCs
05055343872505
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
- 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
- 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
- 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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