# FDA recall Z-2050-2021

> **IMPLANTCAST GMBH** · Class II · device recall initiated 2021-05-10.

## Product

EcoFit cup cementless:  Model(Catalog Number)/Description: 02200046 /EcoFit cup cementless  46mm dia incl. central hole cover; 02200048 /EcoFit cup cementless  48mm dia incl. central hole cover; 02200050 /EcoFit cup cementless  50mm dia incl. central hole cover; 02200052 /EcoFit cup cementless  52mm dia incl. central hole cover; 02200054 /EcoFit cup cementless  54mm dia incl. central hole cover; 02200056 /EcoFit cup cementless  56mm dia incl. central hole cover; 02200058 /EcoFit cup cementless  58mm dia incl. central hole cover; 02200060 /EcoFit cup cementless  60mm dia incl. central hole cover; 02200062 /EcoFit cup cementless  62mm dia incl. central hole cover; 02200064 /EcoFit cup cementless  64mm dia incl. central hole cover; 02200066 /EcoFit cup cementless  66mm dia incl. central hole cover; 02200068 /EcoFit cup cementless  68mm dia incl. central hole cover;

## Reason for recall

A risk exists during impacting of the acetabular cup into the bone the plugs may come loose from the cup, which could lead to operation duration extension or revision operation. A warning note is being added to instructions for use and surgical technique alerting users that the quality of bone in the patient (such as osteosclerosis) is an attributable factor.

## Distribution

U.S. Nationwide distribution in the states of FL and TX.

## Key facts

- **Recall number:** Z-2050-2021
- **Recalling firm:** IMPLANTCAST GMBH
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-05-10
- **Report date:** 2021-07-21
- **Termination date:** 2022-11-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Buxtehude, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2050-2021

## Citation

> AI Analytics. FDA recall Z-2050-2021. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/Z-2050-2021. Source: US FDA. Licensed CC0.

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