Limacorporate S.p.A
9 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Limacorporate S.p.A and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-07-02FDA-DeviceClass IIPRIMA 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.
- 2025-07-02FDA-DeviceClass IIPRIMA 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.
- 2025-01-01FDA-DeviceClass IITEMA 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.
- 2024-01-24FDA-DeviceClass IIPRIMA 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
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.
- 2023-12-20FDA-DeviceClass IIPHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
Due to incorrect product labeling
- 2023-07-05FDA-DeviceClass IIREF 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.
- 2023-07-05FDA-DeviceClass IIREF 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.
- 2023-04-05FDA-DeviceClass IISMR 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.
- 2023-03-22FDA-DeviceClass IITEMA 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.
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