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Limacorporate S.p.A FDA Recalls

11 recalls on file across devices, 0 of them Class I and 9 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, SterileClass IIMay 19, 2025There is the potential that the eccentrical adaptor with scr	There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the posit	Class IIDevices	May 19, 2025
PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, SterileClass IIMay 19, 2025There is the potential that the eccentrical adaptor with scr	There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the posit	Class IIDevices	May 19, 2025
TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented toClass IIOct 2, 2024Due to a potential difference in mechanical behavior between	Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revi	Class IIDevices	Oct 2, 2024
PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610Class IIOct 27, 2023Due to incorrect product labeling	Due to incorrect product labeling	Class IIDevices	Oct 27, 2023
PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPLATE D.25MM REGULAR/1975.14.50Class IIAug 29, 2023Potential for baseplate peripheral holes to be out of specif	Potential for baseplate peripheral holes to be out of specification due to a manufacturing issue, which could	Class IIDevices	Aug 29, 2023
REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile RClass IIMay 30, 2023Due to manufacturing issue, their is a potential for periphe	Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.	Class IIDevices	May 30, 2023
REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE RClass IIMay 30, 2023Due to manufacturing issue, their is a potential for periphe	Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.	Class IIDevices	May 30, 2023
SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210Class IIFeb 21, 2023Shoulder glenoid fossa prosthesis was manufactured without t	Shoulder glenoid fossa prosthesis was manufactured without tantalum markers so in the absence of the markers,	Class IIDevices	Feb 21, 2023
TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)Class IIJan 25, 2023Due to the incorrect component, that is not cleared to be ma	Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow pr	Class IIDevices	Jan 25, 2023
REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01Class IIOct 1, 2021There is a potential that the length of bone screws identifi	There is a potential that the length of bone screws identified on labeling may not correspond to the actual l	Class IIDevices	Oct 1, 2021
REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01Class IIOct 1, 2021There is a potential that the length of bone screws identifi	There is a potential that the length of bone screws identified on labeling may not correspond to the actual l	Class IIDevices	Oct 1, 2021

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