BEUDAMED
    FDA Recall Terminated

    Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory intended for cutting an 11 mm diameter access hole through the cranium of adult patients. Catalog Number: 5100-060-001

    Recall: Z-0431-2021 · Initiated October 16, 2020

    Recall

    Recall Number
    Z-0431-2021
    Event Number
    86670
    Firm
    Stryker Instruments Div. of Stryker Corporation
    FEI Number
    1811755
    Product Code
    HBF
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 16, 2020
    Posted
    November 6, 2020
    Terminated
    June 22, 2022
    Address
    4100 E Milham Ave, Portage, MI, 49002-9704

    Description

    Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory intended for cutting an 11 mm diameter access hole through the cranium of adult patients. Catalog Number: 5100-060-001

    Reason

    Potential for the inner bit to contain a crack, that may or may not be visible, which may lead to metal fragments entering the surgical site and/or delayed disengagment during use.

    Action

    Zimmer issued Medical Device Recall letters via 2-day FedEx shipping on 16OCT2020 stating reason for recall, health risk and action to take: Immediately check your internal inventory to locate the affected products. Quarantine and discontinue use of any affected Disposable Cranial Perforator Bits. 2. Return the enclosed business reply form (BRF) even if you dont have any affected product on hand, via fax (866) 521-2762 or email to [email protected]. 3. If the BRF for your facility indicates that recalled product is currently on hand, a shipping label will be provided which should be used to return recalled product. 4. Upon receipt of the recalled product, Stryker will contact you to arrange for replacement or credit. 5. Maintain awareness of this communication internally until all required actions have been completed within your facility. 6. Inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients appropriately. If you have any questions or concerns, please contact Sylvia Page at (269) 501-8375 or email at [email protected]. Expanded Recall: A second notification Medical Device Recall Expansion Letter letter dated 1/5/21 issued via FedEx second day to the US consignees.

    Distribution

    Nationwide Foreign: Australia Brazil Canada Chile Colombia Hong Kong Italy Mexico Netherlands Netherlands New Zealand South Africa South Korea Spain Sweden Switzerland United Kingdom

    Quantity

    18,492 devices. Expanded Recall total: 18,594 devices