FDA Device recall Z-2009-2023
REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R
- FDA Device
- Class II
- ongoing
- Published 2023-07-05
On 2023-07-05 the FDA classified a Class II recall of REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R by Limacorporate S P A, citing due to manufacturing issue, their is a potential for peripheral holes to be out of specification.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2009-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-30 |
| Published | 2023-07-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Limacorporate S P A |
| Distribution | US |
Product
REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R
Reason
Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.
Identifiers
| code_info | UDI-DI: 08033390244824; All Lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Limacorporate S P A
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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 - 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 · 2024-01-24 · 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
All Limacorporate S P A recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2009-2023%22
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