FDA Device recall Z-2010-2023
REF 1975.14.800, Prima TT Genoid Modular 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 1975.14.800, Prima TT Genoid Modular 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-2010-2023 |
| 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 1975.14.800, Prima TT Genoid Modular 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: 08033390244893; All Lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2010-2023%22
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