LIMACORPORATE S.p.A.
Active in EUDAMEDItalyfrom SRN EUDAMED FDA SRN IT-MF-000010690 FEI 3008021110
Part of Lima Corporate S.P.A.
- Devices
- 40
- Registrations
- EUDAMEDFDA
- FDA recalls
- 169 ongoing
At a glance
EU certificates
6 of 6 in force.
Market reach
- European Union
- EUDAMED actor, 6 certificates
- United States
- FDA FEI, FDA recalls
What LIMACORPORATE S.p.A. makes
Limacorporate S.p.A. manufactures orthopedic implants for hip revision surgery, including tibial augments, bipolar head liners, acetabular cups, and resection/instrumentation sets. Products include modular components like angled spacers and custom-sized liners for acetabular replacements, as well as revision-specific tools for surgical procedures.
The company’s portfolio is regulated under EU Medical Device Regulations as Class IIa and Class III devices, with all products listed in the eudamed database. The manufacturer is based in Italy.
Catalogue
Search and filter all 40 devicesCompany details
- EUDAMED SRN
- IT-MF-000010690
- SRN (system / procedure pack)
- IT-PR-000012691
- FDA FEI number
- 3008021110
- EU VAT number
- 01427710304
- EUDAMED status
- Active
- EUDAMED registered name
- LIMACORPORATE S.p.A.
- EUDAMED abbreviated name
- LIMACORPORATE
- Registered address
- 52, Via Nazionale, 33038, Villanova di San Daniele del Friuli, Italy
- Website
- enovis.com/lima
- [email protected]
- Phone
- +39 0432 945511
- PRRC contact
- Giuseppe Faenza
EUDAMED certificates
6 certificates6 valid, 0 expiredMDR 6next expiry 16 Oct 2027
TÜV SÜD Product Service GmbH 0123 4 certificates
- G11 075731 0074 Reissued
Quality management system EU MDR
- Issued
- 22 May 2025
- Expires
- 21 May 2030
- G13 075731 0072 Reissued
Quality management system EU MDR
- Issued
- 22 May 2025
- Expires
- 21 May 2030
- G10 075731 0077 Restricted
Quality management system EU MDR
- Issued
- 8 Oct 2025
- Expires
- 23 Oct 2027
- Valid from
- 1 Jan 2026
- Reason
- Reduce scope
- G12 075731 0076 Supplemented
Quality management system EU MDR
- Issued
- 27 Nov 2025
- Expires
- 16 Oct 2027
- Reason
- Add device or group
ITALCERT SRL 0426 2 certificates
- 053-00-02-MDR Supplemented
Technical documentation EU MDR
- Issued
- 14 Oct 2025
- Expires
- 10 Sep 2029
- Reason
- Add device or group
- 018-00-09-MDR Supplemented
Quality management system EU MDR
- Issued
- 5 Nov 2025
- Expires
- 3 May 2028
- Reason
- Other
FDA recalls
FDA recall records list 16 recalls initiated by LIMACORPORATE S.p.A., the earliest on 2015-08-14 and the most recent on 2025-05-19. By recorded status: 9 ongoing, 6 terminated and 1 with another status. The reasons filed fall into these groups: labeling or instructions for use, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 1
- 2018 0
- 2019 0
- 2020 0
- 2021 2
- 2022 0
- 2023 6
- 2024 1
- 2025 2
- 2026 0
2025
- 19 May 2025 Z-2024-2025 Class II Ongoing There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.
Full distribution text
- 19 May 2025 Z-2025-2025 Class II Ongoing There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.
Full distribution text
- 19 May 2025 Z-2024-2025 Class II Ongoing There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.
2024
- 2 Oct 2024 Z-0744-2025 Class II Ongoing Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery.
2023
- 27 Oct 2023 Z-0524-2024 Class II Ongoing Due to incorrect product labeling
- 29 Aug 2023 Z-0726-2024 Class II Ongoing 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.
- 30 May 2023 Z-2009-2023 Class II Ongoing Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.
- 30 May 2023 Z-2010-2023 Class II Ongoing Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.
- 21 Feb 2023 Z-1317-2023 Class II Ongoing 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.
- 25 Jan 2023 Z-1261-2023 Class II Ongoing Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.
2021
- 1 Oct 2021 Z-0159-2022 Class II Terminated There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.
Full distribution text
- 1 Oct 2021 Z-0159-2022 Class II Terminated There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.
Show all 16 recalls
2021
- 1 Oct 2021 Z-0160-2022 Class II Terminated There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.
Full distribution text
- 1 Oct 2021 Z-0160-2022 Class II Terminated There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.
2017
- 8 Sep 2017 Z-0068-2018 Class II Completed 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.
Full distribution text
- 8 Sep 2017 Z-0068-2018 Class II Completed 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.
2016
- 21 Jul 2016 Z-2707-2016 Class II Terminated 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.
- 8 Apr 2016 Z-1711-2016 Class II Terminated Complaints of intra-operative breakage of the glenosphere impactors/extractors.
2015
- 14 Aug 2015 Z-2539-2015 Class II Terminated The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.
Full distribution text
- 14 Aug 2015 Z-2540-2015 Class II Terminated The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.
Full distribution text
- 14 Aug 2015 Z-2539-2015 Class II Terminated The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.
Frequently asked questions
How many devices does LIMACORPORATE S.p.A. have in the registry?
The registry currently lists 40 devices for LIMACORPORATE S.p.A.. Devices recorded under merged duplicate company entries are counted once.
Which registries list LIMACORPORATE S.p.A.'s devices?
Among its 40 most recently registered devices, LIMACORPORATE S.p.A. has devices listed in EUDAMED (40 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do LIMACORPORATE S.p.A.'s devices fall under?
Among its 40 most recently registered devices, the classes recorded for LIMACORPORATE S.p.A.'s devices are Class IIa and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for LIMACORPORATE S.p.A.?
FDA recall records list 16 recalls initiated by LIMACORPORATE S.p.A., the most recent initiated on 2025-05-19. 9 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What EUDAMED certificates are recorded for LIMACORPORATE S.p.A.?
EUDAMED lists 6 certificates for LIMACORPORATE S.p.A. (quality management system; technical documentation) under MDR. The most recent was issued on 2025-11-27.
What are the newest devices from LIMACORPORATE S.p.A. in the registry?
The most recently registered devices listed for LIMACORPORATE S.p.A. include MULTIGEN PLUS KNEE - TI6AL4V TIBIAL AUGMENT #1 - H=7MM, MULTIGEN PLUS COCRMO+UHMWPE+TI6AL4V HINGED KNEE H TIBIAL LINER+HINGE #1 - H=12MM, Physica ZUK - Femoral Preparation Instrument Set and MULTIGEN PLUS KNEE - UHMWPE PATELLAR PROSTHESIS DIA 32MM.