Limacorporate S.p.A recalls

8 official recalls and safety alerts involving Limacorporate S.p.A since 2021-10, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Limacorporate S.p.A or the relevant agency.

1. 2025-07-02
2. US
   Drugs & medicalClass II

   Limacorporate S.p.A recalls PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile

   There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.

   FDA · DeviceLimacorporate S.p.AWorldwide - US Nationwide distribution in the states of VA, FL, SC, MS, NY, TX…Official notice →
3. 2025-01-01
4. US
   Drugs & medicalClass II

   Limacorporate S.p.A recalls 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.

   Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery.

   FDA · DeviceLimacorporate S.p.AU.S: FL and TX O.U.S.: N/AOfficial notice →
5. 2024-01-24
6. US
   Drugs & medicalClass II

   Limacorporate S.p.A recalls PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPLATE D.25MM REGULAR/1975.14.500, BASEPLATE D.28MM…

   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.

   FDA · DeviceLimacorporate S.p.AUS: IL, MO, CA, IN, MI, OKOfficial notice →
7. 2023-12-20
8. US
   Drugs & medicalClass II

   Limacorporate S.p.A recalls PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610

   Due to incorrect product labeling

   FDA · DeviceLimacorporate S.p.AU.S Distribution: AZ, CA, IL, LA, and NYOfficial notice →
9. 2023-07-05
10. US
    Drugs & medicalClass II

    Limacorporate S.p.A recalls REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R

    Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.

    FDA · DeviceLimacorporate S.p.AUS Nationwide distribution in the states of MI, IL, ND, MO, OK.Official notice →
11. 2023-04-05
12. US
    Drugs & medicalClass II

    Limacorporate S.p.A recalls SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210

    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…

    FDA · DeviceLimacorporate S.p.AUS: MOOfficial notice →
13. 2023-03-22
14. US
    Drugs & medicalClass II

    Limacorporate S.p.A recalls TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)

    Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.

    FDA · DeviceLimacorporate S.p.AU.S. Distribution to: TXOfficial notice →
15. 2021-10-27
16. US
    Drugs & medicalClass II

    Limacorporate S.p.A recalls REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852

    There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.

    FDA · DeviceLimacorporate S.p.AWorldwide distribution - US Nationwide distribution in the states of CA, FL,…Official notice →