BEUDAMED
    FDA Recall Open, Classified

    Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 579.0103

    Recall: Z-1509-2022 · Initiated July 22, 2022

    Recall

    Recall Number
    Z-1509-2022
    Event Number
    90573
    Firm
    Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom
    FEI Number
    3002806725
    Product Code
    JDI
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    July 22, 2022

    Description

    Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 579.0103

    Reason

    One MetaFix size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix size 3 collared stem from batch 485630.

    Action

    The firm notified its direct consignees of the recall on 07/22/2022 by letter. The notice explained the issue and requested the following actions: "Actions to be taken by the Customer: - Quarantine the devices if not yet performed - Return the devices to Corin Limited, displaying the RGA note on the exterior of the parcel, to: RA/Vigilance Department; Corin Ltd; Corinium Centre; Cirencester; Gloucestershire; GL7 1YJ, United-Kingdom - Complete the acknowledgement of receipt and forward it to the Vigilance department of Corin UK to confirm receipt of this Field Safety Notice/Recall letter."

    Distribution

    US Nationwide distribution in the states of OK, TX, FL.

    Quantity

    5 devices