San Daniele Del Friuli, N/A, Italy
Limacorporate S.p.A recalls
8 recalls recorded since 2018, most recently on 19 May 2025. 7 are listed as ongoing. Status and classification are as published by the FDA.
Recalls8
Ongoing (FDA)7
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 19 May 2025
- Reason
- There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.
- Distribution
- Worldwide - US Nationwide distribution in the states of VA, FL, SC, MS, NY, TX and the countries of Italy, Poland, France.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2025-2025, Z-2024-2025
- PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile
- PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, Sterile
Ongoing Class II Medical devices
- Recall started
- 2 October 2024
- Reason
- Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery.
- Distribution
- U.S: FL and TX O.U.S.: N/A
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0744-2025
- 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.
Ongoing Class II Medical devices
- Recall started
- 27 October 2023
- Reason
- Due to incorrect product labeling
- Distribution
- U.S Distribution: AZ, CA, IL, LA, and NY
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0524-2024
- PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
Ongoing Class II Medical devices
- Recall started
- 29 August 2023
- 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.
- Distribution
- US: IL, MO, CA, IN, MI, OK
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0726-2024
- 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, BAS
Ongoing Class II Medical devices
- Recall started
- 30 May 2023
- Reason
- Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.
- Distribution
- US Nationwide distribution in the states of MI, IL, ND, MO, OK.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2010-2023, Z-2009-2023
- REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R
- REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R
Ongoing Class II Medical devices
- Recall started
- 21 February 2023
- 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 performed by the evaluation of the joint space, central TT peg position and cement mantel observation.
- Distribution
- US: MO
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1317-2023
- SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210
Ongoing Class II Medical devices
- Recall started
- 25 January 2023
- Reason
- Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.
- Distribution
- U.S. Distribution to: TX
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1261-2023
- TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
Terminated Class II Medical devices
- Recall started
- 1 October 2021
- Terminated
- 27 June 2024
- 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.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of CA, FL, MO, KS, CO, TX, KS, IL, PA, NY, NC, MI, MA, OK and the countries of Austria, Croatia, Germany, Ireland, Italy, Japan, Korea, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0159-2022, Z-0160-2022
- REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852
- REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.