FDAMay 30, 2023device
REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.
What to do
FDA enforcement status: Ongoing
Brands named
limacorporate s p alimacorporate
UPCs
08033390244893
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAPRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, Sterile2025-05-19
- FDAPRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile2025-05-19
- FDATEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented total elbow prosthesis.2024-10-02
- FDAPHYSICA HPS Tibial Liner #6 H10 REF 6539.54.6102023-10-27
- FDAPRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPLATE D.25MM REGULAR/1975.14.500, BASEPLATE D.28MM REGULAR/1975.14.800, BASEPLATE D.25MM FULL WEDGED 10-degrees/1975.14.510, BASEPLATE D.28MM FULL WEDGED 10-degrees/1975.14.810, BASEPLATE D.25MM FULL WEDGED 15...2023-08-29
- FDAREF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R2023-05-30
- FDASMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.2102023-02-21
- FDATEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)2023-01-25
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