BEUDAMED
    FDA Recall Terminated

    Rotating Tibial Platform ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home its relevant mating part: Fixed Tibial bearing, (254401003) Rotating Tibial Platform, (254401004) and Femoral impactor, (254401006).

    Recall: Z-0904-2015 · Initiated November 10, 2014

    Recall

    Recall Number
    Z-0904-2015
    Event Number
    70043
    Firm
    DePuy Orthopaedics, Inc.
    FEI Number
    1818910
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 10, 2014
    Posted
    January 5, 2015
    Terminated
    December 8, 2015
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994

    Description

    Rotating Tibial Platform ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home its relevant mating part: Fixed Tibial bearing, (254401003) Rotating Tibial Platform, (254401004) and Femoral impactor, (254401006).

    Reason

    ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produced small pieces. Should a fracture occur and not be observed during surgery, there is the potential for these small fractured pieces of the instrument to be left in the patient.

    Action

    DePuy Synthes sent an Urgent Information letter dated November 10, 2014, to all affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers were instructed to complete the Hospital/User Facility Acknowledgement Car and return to their Deputy Orthopaedics Sales Consultant or fax to 574-371-4939. Customer swere also asked to retain a copy of the complete Acknnowlegement Card in their files along with the notice. Customers with questions were instructed to call 574-371-4917 (M-F; 8 a.m. 5 p.m. EDT). For questions regarding this recall cal 574-371-4917.

    Distribution

    Worldwide Distribution: US (nationwide) including P.R. except AK and RI; and Internationally to: Chile, Canada, Australia, Austria, Belgium, China, France, Ireland, India, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Thailand, United Arab Emirates (UAE), and United Kingdom (UK).

    Quantity

    3861