The Recall Desk

Manufacturer

Limacorporate S.p.A

16 recalls in our database name Limacorporate S.p.A as the manufacturing or recalling firm.

What the numbers show

Total
16
Critical
0
Severe
0
Most recent
2025-07-02

Of the 16 recalls from Limacorporate S.p.A we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–16 of 16

  • HighFDA (Devices)·Z-2025-2025·2025-07-02

    PRIMA 4MM Eccentrical Adaptor With Screw Medical Device Recall

    Limacorporate S.p.A is recalling PRIMA 4MM Eccentrical Adaptor with Screw devices because the black laser marking used to identify positioning may be missing. The defect could affect proper device placement during use.

    Product
    PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2024-2025·2025-07-02

    PRIMA 2MM Eccentrical Adaptor With Screw Sterile Medical Device

    Limacorporate is recalling PRIMA 2MM Eccentrical Adaptor With Screw sterile devices because the black laser marking used to identify position may be missing.

    Product
    PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0744-2025·2025-01-01

    TEMA Elbow System Prostheses Recalled for Mechanical Behavior Concern

    Limacorporate is recalling TEMA Elbow System prostheses due to potential differences in mechanical behavior between implanted devices and surgical revision tools. Approximately 87 devices distributed in Florida and Texas are affected.

    Product
    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.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0726-2024·2024-01-24

    PRIMA TT Shoulder Implant Baseplates Recalled for Manufacturing Defect Risk

    PRIMA TT shoulder implant baseplates are being recalled by Limacorporate due to manufacturing defects in the baseplate peripheral holes that could cause the implant to loosen or the screw to move.

    Product
    PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPLATE D.25MM REGULAR/1975.14.500, BASEPLATE D.28MM REGULAR/1975.14.800, BASEPLATE D.25MM FULL WEDGED 10-degrees/1975.14.510, BASEPLATE D.28MM FULL WEDGED 10-degrees/1975.14.810, BASEPLATE
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0524-2024·2023-12-20

    Medical Device Recall: PHYSICA HPS Tibial Liner Incorrect Labeling

    Limacorporate is recalling 33 PHYSICA HPS Tibial Liner units distributed in the U.S. due to incorrect product labeling. No adverse events have been reported.

    Product
    PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2009-2023·2023-07-05

    Orthopedic Baseplate Recall: Manufacturing Defect in Peripheral Holes

    Limacorporate is recalling Prima TT Genoid Monoblock Reverse TT Baseplates due to a manufacturing issue that may result in peripheral holes being out of specification.

    Product
    REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2010-2023·2023-07-05

    Limacorporate Prima TT Orthopedic Baseplate Recalled for Manufacturing Defect

    Limacorporate is recalling 13 units of the Prima TT Genoid Modular Reverse TT Baseplate due to a manufacturing issue that may cause peripheral holes to be out of specification. Healthcare facilities should contact the manufacturer.

    Product
    REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1317-2023·2023-04-05

    Shoulder Glenoid Prosthesis Implant Manufactured Without Tantalum Markers

    A shoulder glenoid prosthesis implant (SMR TT Hybrid Std - Peg S) was manufactured without tantalum markers that aid in radiographic visualization. While alternative assessment methods using joint space, peg position, and cement observation remain available, the missing markers limit direct imaging capabilities.

    Product
    SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1261-2023·2023-03-22

    TEMA Axle Small elbow prosthesis recalled due to unapproved component

    Limacorporate recalled 5 TEMA Axle Small elbow prostheses due to inclusion of a component not cleared for U.S. marketing. Affected systems were distributed to Texas.

    Product
    TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0160-2022·2021-10-27

    Bone Screw Labeling Error: Actual Length May Not Match Package Label

    Limacorporate is recalling bone screws (REF 8420.15.010) because the actual length of the screws may not correspond to the length stated on the package label, potentially affecting proper surgical placement and implant stability.

    Product
    REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0159-2022·2021-10-27

    Orthopedic Bone Screws Recalled Due to Potential Length Mislabeling

    Limacorporate S.p.A is recalling 151 units of bone screws because the labeled length may not match the actual screw length included in the package.

    Product
    REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0068-2018·2017-11-15

    Lima Delta Cup Beater Positioner Recalled for Potential Welding Defects

    Lima is recalling 20 Delta Cup Beater Positioner units in the US due to suboptimal welding that may reduce mechanical strength and cause breakage during use.

    Product
    Delta Cup Beater  Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2707-2016·2016-09-07

    Limacorporate SMR Allen Wrench Recalled for Dimensional Non-Conformance

    Limacorporate S.p.A is recalling 76 SMR allen wrenches (5 mm) because they are dimensionally non-conforming and may not function with some T-handles.

    Product
    SMR allen wrench 5 mm, product code 9013.50.210
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1711-2016·2016-06-01

    Limacorporate SMR Glenosphere Impactor/Extractor Recalled for Intra-operative Breakage

    Limacorporate is recalling 314 SMR glenosphere impactor/extractor units due to reports of breakage during surgery. The devices were distributed in the US and Australia.

    Product
    SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2540-2015·2015-09-09

    Limacorporate Recalls SMR Shoulder Trial Heads Due to Assembly Issues

    Limacorporate S.p.A is recalling 93 units of SMR Shoulder Trial Heads because dimensions are out of specification, making assembly difficult.

    Product
    SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla Trial Heads ECC .8 mm Adaptor, REF 9013.30.031; for use in shoulder implant surgery.
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-2539-2015·2015-09-09

    Limacorporate Recalls SMR Shoulder Trial Humeral Heads Due to Assembly Issues

    Limacorporate is recalling specific SMR Shoulder Trial Humeral Heads because their dimensions are out of specification, making them difficult to assemble.

    Product
    SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm, REF 9013.22.445; SMR Shoulder/Spalla Trial Humeral Head diameter .46 mm, REF 9013.22.465; for use in shoulder implant surgery.
    Category
    Medical Device
    Distribution
    16 states