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Limacorporate S.p.A Recalls
16 recalls on record · September 9, 2015 to July 2, 2025 · Medical Devices
Recalls by year
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21
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25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 2, 2025Medical DevicesFDA
Limacorporate S.p.A recalls PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile
Hazard: There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.
July 2, 2025Medical DevicesFDA
Limacorporate S.p.A recalls PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, Sterile
Hazard: There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.
January 1, 2025Medical DevicesFDA
Limacorporate S.p.A recalls TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented to
Hazard: Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery.
January 24, 2024Medical DevicesFDA
Limacorporate S.p.A recalls PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPLATE D.25MM REGULAR/1975.14.50
Hazard: Potential for baseplate peripheral holes to be out of specification due to a manufacturing issue, which could lead to loosening of the implant, or the screw moving from its original position.
December 20, 2023Medical DevicesFDA
Limacorporate S.p.A recalls PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
Hazard: Due to incorrect product labeling
July 5, 2023Medical DevicesFDA
Limacorporate S.p.A recalls REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R
Hazard: Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.
July 5, 2023Medical DevicesFDA
Limacorporate S.p.A recalls REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R
Hazard: Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.
April 5, 2023Medical DevicesFDA
Limacorporate S.p.A recalls SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210
Hazard: Shoulder glenoid fossa prosthesis was manufactured without tantalum markers so in the absence of the markers, on already implanted devices, a correct radiographic assessment of the hybrid glenoid position can be performed by the evaluation of the joint space, central TT peg position and cement mantel observation.
March 22, 2023Medical DevicesFDA
Limacorporate S.p.A recalls TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
Hazard: Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.
October 27, 2021Medical DevicesFDA
Limacorporate S.p.A recalls REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01
Hazard: There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.
October 27, 2021Medical DevicesFDA
Limacorporate S.p.A recalls REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01
Hazard: There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.
November 15, 2017Medical DevicesFDA
Limacorporate S.p.A recalls Delta Cup Beater Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System
Hazard: An internal analysis on complaints received indicated that the welding process may have been performed sub optimally in the 12 lot # involved , leading to reduced mechanical strength of the device and possible breakage during impaction when the instrument is subjected to repeated multi-axial stresses.
September 7, 2016Medical DevicesFDA
Limacorporate S.p.A recalls SMR allen wrench 5 mm, product code 9013.50.210
Hazard: Product found to be dimensionally non-conforming (slightly over dimensioned on the diameter of the Zimmer connection) and non-functional for connecting with some T-handles.
June 1, 2016Medical DevicesFDA
Limacorporate S.p.A recalls SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.
Hazard: Complaints of intra-operative breakage of the glenosphere impactors/extractors.
September 9, 2015Medical DevicesFDA
Limacorporate S.p.A recalls SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla Trial Heads ECC .8 mm Adaptor, R
Hazard: The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.
September 9, 2015Medical DevicesFDA
Limacorporate S.p.A recalls SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter
Hazard: The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.