BEUDAMED
    FDA Recall Open, Classified

    WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device Type Part Number XXS 10-702-080095-0 XS 10-702-095115-0 Short 10-702-115150-0 Medium 10-702-140200 Long 10-702-190300-0

    Recall: Z-1102-2023 · Initiated January 4, 2023

    Recall

    Recall Number
    Z-1102-2023
    Event Number
    91526
    Firm
    Wishbone Medical, Inc.
    FEI Number
    3013680140
    Product Code
    KTT
    Status
    Open, Classified
    Root Cause
    Process design
    Initiated
    January 4, 2023
    Posted
    February 7, 2023
    Address
    100 Capital Dr, Warsaw, IN, 46582-6704

    Description

    WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device Type Part Number XXS 10-702-080095-0 XS 10-702-095115-0 Short 10-702-115150-0 Medium 10-702-140200 Long 10-702-190300-0

    Reason

    Firm identified that user may be unable to adjust the length of the Smart Correction Dual Joint Express Struts due to the collar release pin backing out. This may lead to a delay in correction.

    Action

    The firm visited the affected consignee on December 30, 2021, to discuss the product issue.

    Distribution

    US Nationwide distribution in the state of South Carolina.

    Quantity

    195