BEUDAMED
    FDA Enforcement Class II Ongoing

    Identity Shoulder System Resection Planer 35mm Resection Planer

    Recall: Z-1098-2023 · Reported February 15, 2023

    Enforcement

    Recall Number
    Z-1098-2023
    Event ID
    91468
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Zimmer, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 15, 2023
    Initiation Date
    December 7, 2022
    Classification Date
    February 6, 2023
    Address
    1800 W Center St, Warsaw, IN, 46580-2304, United States

    Description

    Identity Shoulder System Resection Planer 35mm Resection Planer

    Reason

    Two planers were found to be unusable during sawbones shoulder training.

    Code Info

    Item Number: 1) SBHA4035; Lots: ZB7298335 (UDI: (01)00889024628052(11)220725(10)ZB7298335); ZB7234012 (UDI: (01)00889024628052(11)220512(10)ZB7234012); ZB3987432 (UDI: (01)00889024628052(11)220308(10)ZB3987432) 2) SBHA4040; Lot ZB7234013 (UDI: (01)00889024628069(11)220512(10)ZB7234013) 3) SBHA4045; Lot ZB7234014 (UDI: (01)00889024628076(11)220525(10)ZB7234014) 4) SBHA4050; Lots: ZB7234015 (UDI: (01)00889024628083(11)220624(10)ZB7234015); ZB3987435 (UDI: (01)00889024628083(11)220312(10)ZB3987435); ZB3986427 (UDI: (01)00889024628083(11)220307(10)ZB3986427) 5) SBHA4055; Lots: ZB7252285 (UDI: (01)00889024628090(11)220704(10)ZB7252285); ZB3986428 (UDI: (01)00889024628090(11)220307(10)ZB3986428); and ZB3987436 (UDI: (01)00889024628090(11)220612(10)ZB3987436).

    Distribution

    US Nationwide distribution in the states of AR, CA, IL, MI, NJ, NY, OK, PA, TX, and WA.

    Quantity

    84 units