# FDA recall Z-0068-2018

> **Limacorporate S.p.A** · Class II · device recall initiated 2017-09-08.

## Product

Delta Cup Beater  Positioner - Aligner, model # 9057.20.555    Used during implantation of the Delta Acetabular System

## Reason for recall

An internal analysis on complaints received indicated that the welding process may have been performed sub optimally in the 12 lot # involved , leading to reduced mechanical strength of the device and possible breakage during impaction when the instrument is subjected to repeated multi-axial stresses.

## Distribution

Worldwide Distribution - US Distribution and to the countries of : Australia, Austria, Belgium, Brazil, Czech Republic, Germany, Italy, New Zealand, Poland, Russia, Slovakia, Slovenia, Spain, South Africa, Switzerland, Turkey, UK and Germany

## Key facts

- **Recall number:** Z-0068-2018
- **Recalling firm:** Limacorporate S.p.A
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2017-09-08
- **Report date:** 2017-11-15

- **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-0068-2018

## Citation

> AI Analytics. FDA recall Z-0068-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0068-2018. Source: US FDA. Licensed CC0.

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