ProMade PoC Center for Complex Orthopedic Solutions at HSS

Activity by year

Devices registered here (6)

• Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  Product code KWT (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3650
• Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
  Product code PAO (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3660
• Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
  Product code HSD (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3690
• Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
  Product code MBF (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3670
• Shoulder Prosthesis, Reverse Configuration
  Product code PHX (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3660
• Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  Product code KWS (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3660

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.

FDA inspections (1)

• VAI2024-01-18
  Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

• All facilities operated by Limacorporate S.p.A.
• Limacorporate S.p.A. (IT)
• Limacorporate S.p.A. (IT)

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)