BEUDAMED
    FDA Recall Open, Classified

    Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Drape/ UDI: HH2000/10858701006329; HH9006/ 10858701006282

    Recall: Z-1925-2020 · Initiated January 7, 2020

    Recall

    Recall Number
    Z-1925-2020
    Event Number
    85474
    Firm
    Stryker Corporation
    FEI Number
    2936485
    Product Code
    MMP
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    January 7, 2020
    Address
    5900 Optical Ct, San Jose, CA, 95138-1400

    Description

    Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Drape/ UDI: HH2000/10858701006329; HH9006/ 10858701006282

    Reason

    Sterile drapes packaged in an unsealed pouch.

    Action

    An URGENT MEDICAL DEVICE RECALL NOTIFICATION letter was sent to the affected customers on 01/07/2020 informing them of the product field action prompting them to send any unused affected units back to the manufacturer.

    Distribution

    US - Nationwide & Puerto Rico OUS - Netherlands, Spain, Switzerland, Colombia, Canada, Japan, Taiwan, Puerto Rico, South Africa, South Korea, Australia, Chile, China, Germany, France, United Kingdom, Hong Kong, India, Italy, Singapore, Thailand, Romania, Belgium, Sweden, Switzerland, Austria, Malaysia, Finland, Denmark, Israel, Qatar, Kazakhstan, Turkey, Czech Republic, Greece, Russia, Poland, Ireland, Philippines, and New Zealand.

    Quantity

    26,298 units