Drug recall
REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R
FDA recall event 92459 · Class II · Limacorporate S.p.A
Key facts
| Event ID | 92459 |
|---|---|
| Recall numbers | Z-2009-2023, Z-2010-2023 |
| Recalling firm | Limacorporate S.p.A |
| Product type | Devices |
| Products | REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R, REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to manufacturing issue, their is a potential for peripheral holes to be out of specification. |
| Initiation date | May 30, 2023 |
| Report date | Jul 5, 2023 |
| City | San Daniele Del Friuli |
| Country | Italy |
| FEI number | 3008021110 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: