Limacorporate S.p.a.
FDA adverse event reports naming Limacorporate S.p.a. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: LIMACORPORATE S.P.A..
- Total reports
- 1,114
- Deaths
- 0
- Injuries
- 754
- Malfunctions
- 350
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedKWS229
- Prosthesis, Shoulder, Non-Constrained, Metal/Polymer CementedKWT150
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedLPH139
- Prosthesis, Shoulder, Hemi-, Humeral, Metallic UncementedHSD135
- Shoulder Prosthesis, Reverse ConfigurationPHX125
- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedLZO71
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH37
- Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, UncementedMBF35
- Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/PolymerHRY31
- Bit, DrillHTW21
Recent recalls
- 2025-06-25Open, ClassifiedProcess design
PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, Sterile
There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.
- 2025-06-25Open, ClassifiedProcess design
PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile
There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.
- 2024-12-20Open, ClassifiedProcess control
TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented total elbow prosthesis.
Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery.
- 2024-01-12Open, ClassifiedDevice Design
PRIMA 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-degrees/1975.14.615, BASEPLATE D.28MM FULL WEDGED 15-degrees/1975.14.815, BASEPLATE D.28MM FULL WEDGED 15-degrees X/1975.14.865, BASEPLATE D.25 MM FULL WEDGED 20-degrees/1975.14.620, BASEPLATE D.28 MM FULL WEDGED 20-degrees/1975.14.820, BASEPLATE D.28 MM FULL WEDGED 20-degrees X/1975.14.870
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.
- 2023-12-09Open, ClassifiedLabeling Change Control
PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
Due to incorrect product labeling
- 2023-06-27Open, ClassifiedDevice Design
REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R
Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.
- 2023-06-27Open, ClassifiedDevice Design
REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R
Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.
- 2023-04-01Open, ClassifiedProcess control
SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210
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.
- 2023-03-16Open, ClassifiedEmployee error
TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.
- 2016-08-31TerminatedNonconforming Material/Component
SMR allen wrench 5 mm, product code 9013.50.210
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.
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