BEUDAMED
    FDA Enforcement Class II Terminated

    S-Rom¿ Total Hip System Poly Liner Packaging: The insert is placed into an inner foil pouch and vacuum sealed; a ring is placed into a Tyvek/PET pouch and sealed; the foil pouch and Tyvek/PET pouch are placed into a nylon outer pouch and sealed. This is then placed into a folding carton, labeled, and shrink-wrapped. Description: Total Hip System Poly Dial¿ Liner is part of the S-ROM¿ Total Hip System. The Liner is fitted inside the acetabular shell; and is the bearing surface for the Head on the S-ROM¿ stem. The S-ROM liner is used for total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Intended Use: Total Hip System Poly Dial Liner is part of the S-Rom Total Hip System. The Liner is fitted inside the acetabular shell; and is the bearing surface for the Head on the S-Rom¿ stem. The S Rom liner is used for total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

    Recall: Z-2414-2012 · Reported September 26, 2012

    Enforcement

    Recall Number
    Z-2414-2012
    Event ID
    62765
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DePuy Orthopaedics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 26, 2012
    Initiation Date
    August 22, 2012
    Classification Date
    September 20, 2012
    Termination Date
    October 9, 2013
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994, United States

    Description

    S-Rom¿ Total Hip System Poly Liner Packaging: The insert is placed into an inner foil pouch and vacuum sealed; a ring is placed into a Tyvek/PET pouch and sealed; the foil pouch and Tyvek/PET pouch are placed into a nylon outer pouch and sealed. This is then placed into a folding carton, labeled, and shrink-wrapped. Description: Total Hip System Poly Dial¿ Liner is part of the S-ROM¿ Total Hip System. The Liner is fitted inside the acetabular shell; and is the bearing surface for the Head on the S-ROM¿ stem. The S-ROM liner is used for total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Intended Use: Total Hip System Poly Dial Liner is part of the S-Rom Total Hip System. The Liner is fitted inside the acetabular shell; and is the bearing surface for the Head on the S-Rom¿ stem. The S Rom liner is used for total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

    Reason

    Orthopaedics, Inc. (DePuy) is issuing a voluntary recall of four lots of the S-ROM" liner because the Carton label has an Incorrect Color Code Series Designation. We have received one complaint regarding this issue.

    Code Info

    Catalogue Lot Number 87-5987 3189424 3312166 3340992 3402685

    Distribution

    Nationwide Distribution including the states of MA, TX, OH, CA, and NC.

    Quantity

    12 liners