# FDA recall Z-2010-2023

> **Limacorporate S.p.A** · Class II · device recall initiated 2023-05-30.

## Product

REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R

## Reason for recall

Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.

## Distribution

US Nationwide distribution in the states of MI, IL, ND, MO, OK.

## Key facts

- **Recall number:** Z-2010-2023
- **Recalling firm:** Limacorporate S.p.A
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-30
- **Report date:** 2023-07-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Daniele Del Friuli, N/A, Italy

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2010-2023

## Citation

> AI Analytics. FDA recall Z-2010-2023. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-2010-2023. Source: US FDA. Licensed CC0.

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