FDA Device recall Z-0726-2024
PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPLATE D.25MM REGULAR/1975.14.500, BASEPLATE D.28MM…
- FDA Device
- Class II
- ongoing
- Published 2024-01-24
On 2024-01-24 the FDA classified a Class II recall of PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPLATE D.25MM REGULAR/1975.14.500, BASEPLATE D.28MM… by Limacorporate S P A, citing 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 origin….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0726-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-08-29 |
| Published | 2024-01-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Limacorporate S P A |
| Distribution | CA, IL, IN, MI, MO, OK |
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 D.25MM FULL WEDGED 15-degrees/1975.14.615, BASEPLATE D.28MM FULL WEDGED 15-degrees/1975.14.815, BASEPLATE D.28MM FULL WEDGED 15-degrees X/1975.14.865, BASEPLATE D.25 MM FULL WEDGED 20-degrees/1975.14.620, BASEPLATE D.28 MM FULL WEDGED 20-degrees/1975.14.820, BASEPLATE D.28 MM FULL WEDGED 20-degrees X/1975.14.870
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.
Identifiers
| code_info | Product Code/UDI-DI: 1975.14.500/08033390244824, 1975.14.800/08033390244893, 1975.14.510/08033390231299, 1975.14.810/08…Product Code/UDI-DI: 1975.14.500/08033390244824, 1975.14.800/08033390244893, 1975.14.510/08033390231299, 1975.14.810/08033390244909, 1975.14.615/08033390244848, 1975.14.815/08033390244916, 1975.14.865/08033390244930, 1975.14.620/08033390231312, 1975.14.820/08033390244923, 1975.14.870/08033390244947 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Limacorporate S P A
- PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, Sterile
FDA Device · Class II · 2025-07-02 · Limacorporate S P A - PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile
FDA Device · Class II · 2025-07-02 · Limacorporate S P A - 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
FDA Device · Class II · 2025-01-01 · Limacorporate S P A - PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
FDA Device · Class II · 2023-12-20 · Limacorporate S P A - REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R
FDA Device · Class II · 2023-07-05 · Limacorporate S P A
All Limacorporate S P A recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0726-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.