Limacorporate S.p.A
Complete recall history across all FDA and CPSC categories — 16 total recalls
Limacorporate S.p.A appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (16)
FDA medical device enforcement actions by Limacorporate S.p.A
| Date | Product | Reason | Class |
|---|---|---|---|
| May 19, 2025 | PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, Sterile | There is the potential that the eccentrical adaptor with screw, black laser m... | Class II |
| May 19, 2025 | PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile | There is the potential that the eccentrical adaptor with screw, black laser m... | Class II |
| Oct 2, 2024 | TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.1... | Due to a potential difference in mechanical behavior between the implanted de... | Class II |
| Oct 27, 2023 | PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610 | Due to incorrect product labeling | Class II |
| Aug 29, 2023 | PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product... | Potential for baseplate peripheral holes to be out of specification due to a ... | Class II |
| May 30, 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 o... | Class II |
| May 30, 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 o... | Class II |
| Feb 21, 2023 | SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210 | Shoulder glenoid fossa prosthesis was manufactured without tantalum markers s... | Class II |
| Jan 25, 2023 | TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt ... | Due to the incorrect component, that is not cleared to be marketed in the U.S... | Class II |
| Oct 1, 2021 | REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=... | There is a potential that the length of bone screws identified on labeling m... | Class II |
| Oct 1, 2021 | REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=... | There is a potential that the length of bone screws identified on labeling m... | Class II |
| Sep 8, 2017 | Delta Cup Beater Positioner - Aligner, model # 9057.20.555 Used during i... | An internal analysis on complaints received indicated that the welding proces... | Class II |
| Jul 21, 2016 | SMR allen wrench 5 mm, product code 9013.50.210 | Product found to be dimensionally non-conforming (slightly over dimensioned o... | Class II |
| Apr 8, 2016 | SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SM... | Complaints of intra-operative breakage of the glenosphere impactors/extractors. | Class II |
| Aug 14, 2015 | SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR ... | The dimensions of the mating features of the recalled products are out of spe... | Class II |
| Aug 14, 2015 | SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoul... | The dimensions of the mating features of the recalled products are out of spe... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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