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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