BEUDAMED
    FDA Enforcement Class II Terminated

    Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hip System intended for use during total hip arthroplasty. The acetabular insert is used in conjunction with PCA Acetabular Shells and Femoral Heads to restore hip joint biomechanics.

    Recall: Z-0281-2016 · Reported November 25, 2015

    Enforcement

    Recall Number
    Z-0281-2016
    Event ID
    72506
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Howmedica Osteonics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 25, 2015
    Initiation Date
    October 15, 2015
    Classification Date
    November 17, 2015
    Termination Date
    June 8, 2017
    Address
    325 Corporate Dr, N/A, Mahwah, NJ, 07430-2006, United States

    Description

    Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hip System intended for use during total hip arthroplasty. The acetabular insert is used in conjunction with PCA Acetabular Shells and Femoral Heads to restore hip joint biomechanics.

    Reason

    Six (6) PCA 10 Degree Hooded Acetabular Insert-Duration 22 mm (ID) have been distributed in the US, although the 22 mm size was inadvertently omitted from 510(k) #K963612.

    Code Info

    Catalog Number:Lot Number; 6299-8-403:23182601; 6299-8-469:19123701; 6299-8-525:29115601; 6299-8-525:22727301; 6299-8-581:17772401; 6299-8-581:28432001.

    Distribution

    Distribution to Virginia only.

    Quantity

    1 unit