BEUDAMED
    FDA Recall Terminated

    Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-401, NDC (01)07613327131475(10)V07241 Product Usage: Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, and bone and soft tissue reconstruction in pediatric patients and adults.

    Recall: Z-2160-2017 · Initiated April 26, 2017

    Recall

    Recall Number
    Z-2160-2017
    Event Number
    77148
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    KTT
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 26, 2017
    Terminated
    February 7, 2020
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2006

    Description

    Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-401, NDC (01)07613327131475(10)V07241 Product Usage: Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, and bone and soft tissue reconstruction in pediatric patients and adults.

    Reason

    Stryker is recalling Hoffmann LRF (Limb Reconstruction Frame) System Safety Clip - Bone Transport Strut because there is a potential for loosening of the safety clips from the intended position on the Quick Release mechanism of the Transport Struts.

    Action

    Stryker sent via FedEx an "Urgent Medical Device Recall Notification and Business Reply Form" dated April 26, 2017 to their affected customers. For questions call (201) 831-6693.

    Distribution

    US Nationwide distribution in the states of CA, FL, MD and VT

    Quantity

    437 units