Limacorporate S.p.A.
Villanova di San Daniele Udine, IT
Limacorporate S.p.A. appears in FDA device records in Villanova di San Daniele Udine, IT. FDA records list 4 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 16 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Limacorporate S.p.A. between 2019 and 2025. The busiest year on record is 2019, with 1. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2019 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K243809 | Biolox® Delta Revision heads | LZO | Substantially Equivalent | |
| K213785 | SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid | KWS | Substantially Equivalent | |
| K211938 | Physica LMC Knee System | JWH | Substantially Equivalent | |
| K190911 | Physica KR Liner and SMR Reverse Humeral Liner | JWH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008021110 | 3008021110 | Limacorporate S.p.A. | Via Nazionale 52, Villanova di San Daniele Udine 33038 IT | 2026 | and 30 more, listed in full below |
| 3008395353 | 3008395353 | Limacorporate S.p.A. | Zona Industriale Contrada Fegotto, Calatafimi Segesta (TP) Sicilia 91013 IT | 2026 | and 6 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HWJAwl
- HTWBit, Drill
- HRWDynamometer, Nonpowered
- PIXElbow Joint Metal/Polymer, Constrained, Porous Coated, Uncemented Prosthesis
- HWBExtractor
- HTDForceps
- HTJGauge, Depth
- FZXGuide, Surgical, Instrument
- OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
- HWAImpactor
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- LXHOrthopedic Manual Surgical Instrument
- HTYPin, Fixation, Smooth
- HTCPliers, Surgical
- JDCProsthesis, Elbow, Constrained, Cemented
- JDBProsthesis, Elbow, Semi-Constrained, Cemented
- KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- KWAProsthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
- HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
- MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- PAOProsthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
- KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
- PKCProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
- HTOReamer
- HXXScrewdriver
- PHXShoulder Prosthesis, Reverse Configuration
- HWTTemplate
- HWKTrephine
- HXCWrench
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2025-2025 | 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. | Class II | Open, Classified | |
| Z-2024-2025 | 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. | Class II | Open, Classified | |
| Z-0744-2025 | 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. | Class II | Open, Classified | |
| Z-0524-2024 | PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610 | Due to incorrect product labeling | Class II | Open, Classified | |
| Z-0726-2024 | 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. | Class II | Open, Classified | |
| Z-2010-2023 | 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. | Class II | Open, Classified | |
| Z-2009-2023 | 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. | Class II | Open, Classified | |
| Z-1317-2023 | 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. | Class II | Open, Classified | |
| Z-1261-2023 | 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. | Class II | Open, Classified | |
| Z-0160-2022 | REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845 | There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included. | Class II | Terminated | |
| Z-0159-2022 | REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852 | There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included. | Class II | Terminated | |
| Z-0068-2018 | Delta Cup Beater Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System | 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. | Class II | Completed | |
| Z-2707-2016 | 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. | Class II | Terminated | |
| Z-1711-2016 | SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement. | Complaints of intra-operative breakage of the glenosphere impactors/extractors. | Class II | Terminated | |
| Z-2540-2015 | SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla Trial Heads ECC .8 mm Adaptor, REF 9013.30.031; for use in shoulder implant surgery. | The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble. | Class II | Terminated | |
| Z-2539-2015 | SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm, REF 9013.22.445; SMR Shoulder/Spalla Trial Humeral Head diameter .46 mm, REF 9013.22.465; for use in shoulder implant surgery. | The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain