BEUDAMED
    FDA Recall Open, Classified

    Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from 5.5 to 8.5mm in diameter and from 21 24mm in length.

    Recall: Z-1072-2022 · Initiated April 7, 2022

    Recall

    Recall Number
    Z-1072-2022
    Event Number
    89972
    Firm
    Synthes (USA) Products LLC
    FEI Number
    3008812560
    Product Code
    KWI
    Status
    Open, Classified
    Root Cause
    Labeling Change Control
    Initiated
    April 7, 2022
    Address
    1301 Goshen Pkwy, West Chester, PA, 19380-5986

    Description

    Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from 5.5 to 8.5mm in diameter and from 21 24mm in length.

    Reason

    DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis.

    Action

    DePuy Synthesis issued Urgent: MEDICAL DEVICE CORRECTION (Notification) on 4/14/22. Letter states reason for recall, health risk and action to take: " Download and review the updated version of the e-IFU from the following website: https://www.e-ifu.com/search-document-metadata/radial%20head%20replacement%20system Forward this notice to all attending surgeons in your facility using this device. " Please complete, sign, and return the Business Reply Form within three (3) business days email to [email protected] (Please reference FA 2097468 in the subject line). Note: Product is NOT being removed from the field and does not need to be returned.

    Distribution

    US Nationwide distribution.