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Terminated

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;

FDA Recall Z-2050-2021 · Posted 2021-07-09

Recalling FirmIMPLANTCAST GMBH
Recall StatusTerminated
Product CodeLZO
Date Initiated2021-05-10
Date Terminated2022-11-18
Product Quantity41 units (U.S.)

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.

Firm Action

On May 10, 2021 Urgent Safety Information notices were emailed to customers who were asked to take the following action: 1. Read this safety information carefully and make sure all relevant departments and officeholders are informed about its content. 2. Keep this safety information. 3. Fill in and return the reply form. Customers with additional questions were encouraged to contact Wendy Ryan-Kettler at [email protected] On 17 May, 2017, a follow-up Medical Device Correction notice was emailed to customers who were asked to take the following additional actions: 4. Destroy the affected (previous) surgical technique and instruction for use (IFU) and replace them with the updated versions that accompanied this safety information.

Root Cause

Device Design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K163577Ecofit® Hip SystemImplantcast GmbH · 2017-09-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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