BEUDAMED
    FDA Recall Terminated

    JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial baseplate.

    Recall: Z-1045-2019 · Initiated December 10, 2018

    Recall

    Recall Number
    Z-1045-2019
    Event Number
    81766
    Firm
    Smith & Nephew, Inc.
    FEI Number
    1020279
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 10, 2018
    Terminated
    November 3, 2020
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804

    Description

    JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial baseplate.

    Reason

    Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch

    Action

    The firm, smith&nephew, initiated the recall by email with an "Urgent Medical Device Recall Notice" letter dated 12/10/18 to the customers on 12/10/2018. Letter describes the product, problem and actions to be taken. The customers were instructed to do the following: -Inspect your inventory and locate any devices from the listed product and batch numbers and quarantine them immediately. - If you are a distributor, you must notify your customers of the field action and ensure that these actions are carried out. -Complete and return the Response Form to [email protected] or fax to 901-566-7975. Please Note even if you have no product to return, this form must be completed, signed and returned. If you have any questions or concerns regarding this recall please contact [email protected].

    Distribution

    US Distribution to OR and TN; and Internationally to: Japan.

    Quantity

    46 units