REF 1975 — Class II medical device recall Z-2009-2023
Ongoing recall by Limacorporate S.p.A, reported 2023-07-05, distributed nationwide. Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.
| Recall number | Z-2009-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Limacorporate S.p.A, San Daniele Del Friuli, N/A, Italy |
| Recall initiated | 2023-05-30 |
| Classified | 2023-06-27 |
| Reported by FDA | 2023-07-05 |
| Distributed | Nationwide (US) |
| Quantity | 13 units |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 08033390244824 |
| Lot numbers | 1975.14.500 |
| Model numbers | 1975.14.500 |
Product
REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R
Reason for recall
Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2009-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.