BEUDAMED
    FDA Recall Terminated

    1. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-110-100, UDI: (01)4546540861641; 2. InterPulse Handpiece with Coaxial High Flow Tip, Product Number: 0210-114-100, UDI: (01)4546540861764; 3. InterPulse Handpiece with Retractable Coaxial Fan Spray Tip, Product Number: 0210-118-200, UDI: (01)4546540861818; 4. InterPulse Irrigation Only Handpiece with Fan Spray Tip, Product Number: 0210-218-000, UDI: (01)4546540144300 for orthopedic use.

    Recall: Z-1246-2018 · Initiated November 9, 2017

    Recall

    Recall Number
    Z-1246-2018
    Event Number
    79418
    Firm
    Stryker Instruments Div. of Stryker Corporation
    FEI Number
    1811755
    Product Code
    FQH
    Status
    Terminated
    Root Cause
    Environmental control
    Initiated
    November 9, 2017
    Terminated
    April 16, 2019
    Address
    4100 E Milham Ave, Portage, MI, 49002-9704

    Description

    1. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-110-100, UDI: (01)4546540861641; 2. InterPulse Handpiece with Coaxial High Flow Tip, Product Number: 0210-114-100, UDI: (01)4546540861764; 3. InterPulse Handpiece with Retractable Coaxial Fan Spray Tip, Product Number: 0210-118-200, UDI: (01)4546540861818; 4. InterPulse Irrigation Only Handpiece with Fan Spray Tip, Product Number: 0210-218-000, UDI: (01)4546540144300 for orthopedic use.

    Reason

    Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

    Action

    Letters dated November 16, 2017, were sent to customers. Actions to be taken by the Customer/User: 1. Immediately review this Recall Notification. 2. Check all stock areas and/or operating room storage to determine if any devices from the affected lots are at your facility. 3. Quarantine and discontinue use of the recalled devices. 4. Complete and sign the enclosed Business Reply Form (BRF). 5. If you have further distributed these products, please forward this letter and the attached BRF to all affected locations. Please indicate each location on the BRF. 6. Return the completed BRF to Stryker Instruments Post Market Regulatory Compliance via fax (866-521- 2762) or email ([email protected]). 7. If the BRF for your facility indicates that recalled product is currently on hand, a FedEx label will be emailed to you. This shipping label should be used to return recalled product. Upon receipt of the recalled product, a credit will be issued to your account. 8. Report any adverse events associated with the use of these devices to Stryker Instruments 1-800-253-3210, including any infections potentially associated with the use of affected product.

    Distribution

    Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.

    Quantity

    5988