BEUDAMED
    FDA Recall Terminated

    ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non-sterile, these instruments are packed non-sterile, within a rigid tube with foam protectors, with label and IFU

    Recall: Z-0650-2017 · Initiated October 25, 2016

    Recall

    Recall Number
    Z-0650-2017
    Event Number
    75540
    Firm
    Depuy Orthopaedics Inc.
    FEI Number
    1818910
    Product Code
    MEH
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    October 25, 2016
    Posted
    November 21, 2016
    Terminated
    June 6, 2017
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994

    Description

    ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non-sterile, these instruments are packed non-sterile, within a rigid tube with foam protectors, with label and IFU

    Reason

    DePuy Orthopaedics, Inc. is issuing a voluntary recall for all lots of the ACTIS Flex Reamers due to the instruments breaking and potentially leaving pieces in the patient.

    Action

    Depuy Orthopaedics initiated a recall on October 25, 2016. Notices were sent to the US Distributors via email on October 25, 2016. Customers were instructed to do the following: 1. Immediately Inspect Inventory, 2. Immediately Return US Distributor Inventory: If any affected instruments are found in a US Distributors inventory, return to: DePuy Synthes Joint Reconstruction, a division of DePuy Orthopaedics, Inc. 3. To expedite the return and credit process: Be sure to reference H16-14 on all return paperwork and/or online return forms and on the outside of the box when returning recalled lots of the instrument. 4. Upon receipt of the affected instruments, affected instruments will be credited against the US Distributors B&R budget. 5. Within 5-Business Days: Complete the Distributor Card or for the Reconciliation Form: Within 5-business days of initiation, the completed Reconciliation Form should be returned to DePuy Orthopaedics, Inc. 6. Retain copies of all field action documents in customer files For further questions please call (574) 371-4917.

    Distribution

    US Distribution to the states of: CA, KY, LA, MD, ME, NC, NH, NY, TX, VA, WA Foreign: Austria, Ireland, and Japan VA/DOD:

    Quantity

    137