RegWardenFDA facility compliance records
Facility

Limacorporate S.p.A.

12 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2015: 1 recalls; 2016: 2 recalls; 2017: 1 recalls; 2021: 1 recalls; 2023: 5 recalls; 2024: 1 recalls; 2025: 1 recalls1201522016120172018201920201202120225202312024120252026
  • Recalls (12)

Devices registered here (3)

  • Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
    Product code JWH (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3560
  • Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
    Product code MBH (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3565
  • Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
    Product code HRY (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3530

Recalls & enforcement

  • Class IIOngoing2025-05-19
    There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.
  • Class IIOngoing2024-10-02
    Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery.
  • Class IIOngoing2023-10-27
    Due to incorrect product labeling
  • Class IIOngoing2023-08-29
    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.
  • Class IIOngoing2023-05-30
    Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.
  • Class IIOngoing2023-02-21
    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 performed by the evaluation of the joint space, central TT peg posit…
  • Class IIOngoing2023-01-25
    Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.
  • Class IITerminated2021-10-01
    There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.
  • Class IICompleted2017-09-08
    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 during impaction when the instrument is subjected to repeated…
  • Class IITerminated2016-07-21
    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.
  • Class IITerminated2016-04-08
    Complaints of intra-operative breakage of the glenosphere impactors/extractors.
  • Class IITerminated2015-08-14
    The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Limacorporate S.p.A. (FEI 3008395353) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008395353-limacorporate-s-p-a/

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