Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in ItalyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of EnovisLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Limacorporate S.p.A with 16 device recalls and 4 510(k) clearances. The most recent is a device recall dated May 19, 2025: PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| May 19, 2025 | PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, SterileClass II · There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be | Device recalls |
| May 19, 2025 | PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, SterileClass II · There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be | Device recalls |
| Mar 4, 2025 | Biolox® Delta Revision headsK243809 · LZO | 510(k) clearances |
| Oct 2, 2024 | TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented total elbow prosthesisClass II · Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surge | Device recalls |
| Oct 27, 2023 | PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610Class II · Due to incorrect product labeling | Device recalls |
| Aug 29, 2023 | PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPLATE D.25MM REGULAR/1975.14.500, BASEPLATE D.28MMClass II · Potential for baseplate peripheral holes to be out of specification due to a manufacturing issue, which could lead to lo | Device recalls |
| May 30, 2023 | REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile RClass II · Due to manufacturing issue, their is a potential for peripheral holes to be out of specification. | Device recalls |
| May 30, 2023 | REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE RClass II · Due to manufacturing issue, their is a potential for peripheral holes to be out of specification. | Device recalls |
| Feb 21, 2023 | SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210Class II · Shoulder glenoid fossa prosthesis was manufactured without tantalum markers so in the absence of the markers, on already | Device recalls |
| May 13, 2022 | SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidK213785 · KWS | 510(k) clearances |
| Jul 13, 2021 | Physica LMC Knee SystemK211938 · JWH | 510(k) clearances |
| Nov 26, 2019 | Physica KR Liner and SMR Reverse Humeral LinerK190911 · JWH | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
