BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported February 15, 2023

    Enforcement

    Recall Number
    Z-1102-2023
    Event ID
    91526
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Wishbone Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 15, 2023
    Initiation Date
    January 4, 2023
    Classification Date
    February 7, 2023
    Address
    100 Capital Dr, Warsaw, IN, 46582-6704, United States

    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.

    Code Info

    XXS, Part No. 10-702-080095-0 UDI-DI B5621070208009500 Lot 1048176, 1048221 XS, Part No. 10-702-095115-0 UDI-DI B5621070209511500 Lot 1048177 Short, Part No. 10-702-115150-0 UDI-DI B5621070211515000 Lot 1048178, 1048222, 1048223 Medium, Part No. 10-702-140200 UDI-DI B562107021402000 Lot 1048179 Long, Part No. 10-702-190300-0 UDI-DI B5621070219030000 Lot 1048180

    Distribution

    US Nationwide distribution in the state of South Carolina.

    Quantity

    195