Limacorporate S P A recalls
Limacorporate S P A appears in 16 official U.S. recall notices indexed by RecallRadar, most recently on 2025-07-02.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 16 |
|---|---|
| Published | 2015-09-09 to 2025-07-02 |
| By agency | FDA Device (16) |
| By classification | Class II (16) |
| By status | ongoing (9), terminated (6), completed (1) |
| Distribution named in notices | AL, AZ, CA, CO, FL, IL, IN, KS, LA, MI, MN, MO, MT, NC, NV, NY, OH, OK, TX, US, WA |
Recalls
- PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, Sterile
FDA Device · Class II · 2025-07-02 · Limacorporate S P A
Reason: There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing. - PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile
FDA Device · Class II · 2025-07-02 · Limacorporate S P A
Reason: There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing. - 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
FDA Device · Class II · 2025-01-01 · Limacorporate S P A
Reason: Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery. - PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPLATE D.25MM REGULAR/1975.14.500, BASEPLATE D.28MM…
FDA Device · Class II · 2024-01-24 · Limacorporate S P A
Reason: 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. - PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
FDA Device · Class II · 2023-12-20 · Limacorporate S P A
Reason: Due to incorrect product labeling - REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R
FDA Device · Class II · 2023-07-05 · Limacorporate S P A
Reason: Due to manufacturing issue, their is a potential for peripheral holes to be out of specification. - REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R
FDA Device · Class II · 2023-07-05 · Limacorporate S P A
Reason: Due to manufacturing issue, their is a potential for peripheral holes to be out of specification. - SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210
FDA Device · Class II · 2023-04-05 · Limacorporate S P A
Reason: 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 perform… - TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
FDA Device · Class II · 2023-03-22 · Limacorporate S P A
Reason: Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis. - REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845
FDA Device · Class II · 2021-10-27 · Limacorporate S P A
Reason: There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included. - REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852
FDA Device · Class II · 2021-10-27 · Limacorporate S P A
Reason: There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included. - Delta Cup Beater Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System
FDA Device · Class II · 2017-11-15 · Limacorporate S P A
Reason: 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… - SMR allen wrench 5 mm, product code 9013.50.210
FDA Device · Class II · 2016-09-07 · Limacorporate S P A
Reason: 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. - SMR glenosphere impactor/extractor
FDA Device · Class II · 2016-06-01 · Limacorporate S P A
Reason: Complaints of intra-operative breakage of the glenosphere impactors/extractors. - SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021
FDA Device · Class II · 2015-09-09 · Limacorporate S P A
Reason: The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble. - SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425
FDA Device · Class II · 2015-09-09 · Limacorporate S P A
Reason: The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.